Click here to see, Jobs of the week 31/07/14

Here are CK Clinical’s job of the week for 31/07/14!

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Senior Clinical Programmer – South East

 

Medical/QA jobs

Interim Head, Clinical Trials – London

Early Phase Medical Clinician – London

Clinical Development Scientist – South East

 

Clinical Operations

Global Studies Manager – South East

Manager, Clinical Outsourcing – South East

Administrative Coordinator – South East

 

Regulatory Affairs

Regulatory Affairs Officer – South East

 

PV/Med Affairs

Key Account Manager – South East

Medical Science Liaison – Midlands

Medical Science Liaison – Ireland

Drug Safety Advisor – South East

Medical Science Liaison – Northern UK

 

For a more comprehensive job search, click here!

 

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Medical Science Liaison

Hendre Moolman is recruiting for a Medical Science Liaison to join a leading pharmaceutical company in the south and south west.

The role will be field based and focused on the Oncological and Immunological sectors. You will be supporting healthcare professionals in a scientific and medical capacity, responding to requests in regards to the specialised areas.

A PhD, Masters or Pharmacist qualification is needed, as is relevant experience in the medical or pharmaceutical industries.

For more information, please click here

 

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Senior Pharmacovigilance/ Deputy QP – London

Hendre Moolman is recruiting for a Senior Pharmacovigilance professional to work as a Deputy QP to join an expanding pharmaceutical company at their site in London on a permanent basis.

Responsibilities for this role include supporting the QPPV function locally and globally to ensure compliance with EU PV Legislation and EU Regulations and maintaining a robust compliance programme including company policies and Standard Operating Procedures (SOP’s).

To be considered for this rol you must have proven experience in Pharmacovigilance, at least 3 years QPPV office experience and expert knowledge of managing PSMF.

For more information on this role, or to apply, click here

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Senior Pharmacovigilance Office – West Yorkshire

Farhad Hamayon Salam is recruiting for a Senior Pharmacovigilance Officer to join a leading pharmaceutical company in West Yorkshire on a permanent basis.

Responsibilities include preparing PSUR’s to maintain licences for designated products and reporting ADR’s to regulatory authorities.

Our client is looking for a pharmacovigilance professional with a degree in either biomedical or life sciences.

For more information or to apply click here

 

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Clinical Safety Scientist – London

Farhad Salam is recruiting for a Clinical Safety Scientist to join a company in the pharmaceutical industry for a contract position in London.

In this position you will be required to support the continued safety monitoring and evaluation of assigned products in clinical development and/or post-marketing setting.

If you are experienced in Pharmacovigilence and have excellent communication skills, this could be a great opportunity for you.

Click here for more information or to apply >

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Pharmacovigilance Directors – Home Counties

Jim Gleeson is recruiting for 3 Pharmacovigilance Directors for a contract role at the EU Head Quarters of a highly successful pharmaceutical company based in the Home Counties.

Duties will include leading the pharmacovigilance activities for products in clinical development, and on the market, within the areas of oncology, neurology or primary care.

The successful candidates will need to have a medical degree, as well as extensive pharmacovigilance experience.

Click here to read more and to apply

 

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PV Process Excellence Coordinator – South East, London

Hendre Moolman at CK Clinical is recruiting for a PV Process Excellence Coordinator to join a company in the pharmaceutical industry in a fixed term contract role in the South East.

Responsibilities:

As a PV Process Excellence Coordinator you will be responsible for working across the PV team to understand and refine the processes to drive efficiencies and consistency. You will be working with the Head of PV Operations, existing members of the team, global PV colleagues, and colleagues in other departments, to help improve daily processes.

Further responsibilities of PV Process Excellence Coordinator position will include:

  • Leading matrix teams within the local PV team, to help bring consistency in working practice and to strengthen overall PV operations
  • Playing a leading role in the creation of streamlined processes both within the team and in a cross functional and global setting
  • Being responsible for the development and driving better ways of working and also project managing some important process improvement initiative while playing a key role in the training and implementation of these
  • Being involved in the creation and maintenance of appropriate SOPs and WPs
  • Facilitating the implementation of some aspects of the new PV legislation
  • Working together with Head of PV Operations to help strengthen and streamline operations, including any process improvements to create a highly effective and compliant operation.
  • Coordinating cross departmental process improvement activities to strengthen PV working with colleagues.
  • Playing a key role in leading PV operational projects including facilitating complex discussions in matrix teams to successful outcome.
  • Undertaking other activities and projects as required by line manager and to help ensure high quality documentation, guidance and training are in place.
  • Collaborating with other members of the department, including global colleagues and working in collaboration with the PV ICSR manager and PV Scientific Manager as required
  • Interacting with colleagues in clinical, clinical operations or regulatory and possibly IT

Qualifications:

As PV Process Excellence Coordinator you will have the following qualifications, skills and experience:

  • Science Degree (e.g. pharmacy, Nursing, Life Science).
  • Proven experience in pharmacovigilance including case handling, aggregate reports, other PV deliverables
  • Experience of coordinating project improvement initiatives and in leading matrix teams to a successful outcomes, including at a global level.
  • Extensive knowledge of global PV regulatory legislation (both pre and post marketing) including the new EU legislation
  • Strong understanding of PV business, in a global setting.
  • Proven ability in project delivery, including writing working practices and SOPs, training and implementation of new processes
  • Demonstrated experience of leading process improvement initiatives
  • Possessing a strong sense of responsibility and having a good track record of working to strict deadlines
  • Excellent organisation, coordination or project management skills
  • Good communication and facilitation skills
  • A quick thinking decision maker and problem solver
  • Leadership and drive – in pursuit of operational excellence
  • Proven ability to identify streamlining opportunities and to take projects forward.
  • Excellent negotiation skills -with an ability to reach consensus despite disparate views
  • A creative thinker with a sense of urgency
  • Ability to work consistently and autonomously, seeking advice where necessary
  • Able to form strong cross-departmental and cross-functional relationships

Benefits:

As a PV Process Excellence Coordinator you will be joining a global pharmaceutical company based in the South East.

  • You will be working with a global company
  • You will have a competitive salary
  • 2 year fixed term contract role
Hendre Moolman - Pharmacovigilance Recruitment

Please contact Hendre for more details.

How to apply:

Apply online:

For more information or to apply for this PV Process Excellence Coordinator position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25881 in all correspondence.

 

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Global Pharmacovigilance Regional Head – London, Hertfordshire, South East

Hendre Moolman is recruiting for a Global Pharmacovigilance Regional Head to join a pharmaceutical company in a permanent r

ole in Hertfordshire.

 

As a Global Pharmacovigilance Regional Head the main purpose of your role you will be to manage Pharmacovigilance / Safety and Medical Information projects in regions (Asia Pacific, Americas, Europe, Middle East and Africa) where the company has a presence, providing medical expertise for Medical, Drug Safety/Pharmacovigilance and other corporate functions.

 

 

Responsibilities:

Further responsibilities of this Global Pharmacovigilance Regional Head position will include:

  • Establish Pharmacovigilance function in countries of the applicable Regions.
  • Train & support the Local Pharmacovigilance Responsible Person for specific region to perform Pharmacovigilance activities in their respective countries
  • Ensure the process set forth by Global Pharmacovigilance including ICSR(s), Aggregate Reports PSUR, DSUR) are written & reported to respective regulators with maintaining the highest level of compliance
  • Perform Pharmacovigilance review of protocols, CSR’s, PSUR’s, PADER’s, DSUR’s
  • Establish, support & facilitate routine Pharmacovigilance activities such as case processing, aggregate report, and signal detection
  • Oversee & perform routine quality checks on the activities that are outsourced to third party vendors on behalf of the company’s Pharmacovigilance function in countries of the applicable regions.
  • Train & support the Local Pharmacovigilance Responsible Person for specific region to perform PV activities in their respective countries able Pharmacovigilance
  • Settings, appraisal and management of direct line reports
  • Support internal & external inspections and audits from regulators & third party vendors
  • Support Global Head of Pharmacovigilance with process, structure, budgets and strategy decisions
  • Support function of the QPPV in Europe
  • Ensure the compliance of Global Pharmacovigilance system by working collaboratively with internal & external company personal

 

 

Qualifications, Skills and Experience:

As Global Pharmacovigilance Regional Head you will have the following qualifications, skills and experience

  • Graduate/post graduate in pharmacy/medicine/life science with very strong experience in pharmacovigilance
  • Direct PV experience or previous experience of clinical research is necessary
  • Expertise in a particular medical area preferred
  • Experienced in and knowledgeable about clinical development processes
  • Knowledge of regional drug authority regulations, GCP, ICH
  • Proven ability with high level influencing and negotiation skills
  • Excellent communicator with ability to educate and influence decisions through clear written and verbal communications
  • Strong organisational skills and detail oriented
  • Self-motivator
  • Dedication to quality in all work tasks and deliverables

As Global Pharmacovigilance Regional Head you will be joining a global pharmaceutical company based in Hertfordshire on a permanent role. This exciting opportunity offers a competitive salary and the opportunity to build on management experience.

 

 

 

Apply Now:

Hendre Moolman - Pharmacovigilance Recruitment at CK Clinical

Contact Hendre for more details.

Click here to apply online now >

 

For more information or to apply for this Global Pharmacovigilance Regional Head position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25286 in all correspondence.

 

 

Not quite what you’re looking for?

Click here to search our current pharmacovigilance positions online now.

 

Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East

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Medical Information Manager Job in Germany

Mylene Paumier at CK Clinical is recruiting for a Medical Information Manager to join a global pharmaceutical company at their site based in Germany on a permanent basis.

Medical Information Manager Job Description:

As Medical Information Manager you will be responsible for:

  • Management and accountable for correctness, actuality, plausibility, consistency and safety of all informative texts (spc, leaflet, publicity)
  • Medical-pharmaceutical consulting hotline
  • Medical and pharmaceutical correspondence with patients, pharmacists, doctors
  • Correspondence with agencies wrt leaflet and spc
  • Contact point for any medical and pharmaceutical queries from internally or externally, in close cooperation with QA

As Medical Information Manager, you will also be responsible for managing all local aspects of PV for DEA:

  • Cooperating with EU PV team wrt Psurs, audits
  • Collect quality information concerning adverse drug reactions (ADRs) with Company products
  • Follow-up local cases for further clarification with the reporter and HCPs and completeness when necessary (according to the SOP)
  • Forward the ADR/AE information to the Pharmacovigilance Department Region II as per the applicable SOP
  • Complete the management and reporting of processed AE/ADR cases received locally or from the Region II Pharmacovigilance Department to the local CA if required in accordance with local regulations
  • Ensure the receipt of product quality complaints and communication to the Medical Information team
  • Ensure timely submission of the PSURs distributed to them and maintain a submission log
  • Ensure local literature monitoring
  • Upon the receipt of the updated Reference Safety Information inform Regulatory Departments of variation requirements to the local SPCs;
  • Ensure and monitor Pharmacovigilance compliance with local regulations;
  • Notify the EEA QPPV regarding any new or additional national Pharmacovigilance requirements for the countries of responsibility

Qualifications, Skills and Experience:

To be considered for this Medical Information Manager position, you will have the following qualifications, skills and experience:

  • Excellent and broad pharmaceutical and pharmacological knowledge
  • Excellent understanding and knowledge of relevant local end EU legislation, guidelines and best practice related to pharmacovigilance and medical information
  • Practical work experience in a public or hospital pharmacy
  • Good understanding of technical aspects (regulatory timelines and requirements, QA, IP, manufacturing  aspects etc)
  • Excellent German and fluent English

How to Apply:

Medical Information Manager Job in Germany

Please contact Mylene for more details.

Click here to apply online >

For more information or to apply for this Medical Information Manager position, please contact Mylene Paumier on 01438 743047 or email: mpaumier@ckclinical.co.uk. Please quote reference CL24562 in all correspondence.

 

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Pharmacovigilance Specialist Job in Cambridgeshire

Hendre Moolman at CK Clinical is currently recruiting for a Pharmacovigilance Specialist to join a successful pharmaceutical company based in Cambridgeshire.

 

Pharmacovigilance Specialist Job Description

As Pharmacovigilance Specialist, you will be responsible for the overall coordination of serious adverse event (SAE) processes and database activities and the PVG coordination of sponsor and investigator meetings. You must maintain knowledge and understanding of SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues. In addition, you  will help prepare for and attend audits, kick-off and investigator meetings. The Senior Safety Specialist will act as mentor to new staff.

Further responsibilities of this Pharmacovigilance Specialist position include:

  • Set up and maintain accurate data within the SAE tracker for all assigned projects.
  • Set up and QC of data entry into safety database.
  • Prepare and submit client SAE notifications.
  • Review SAE reports for completeness, clinical consistency and agreement with source documents.
  • Identify and send SAE queries to investigator sites either directly or through CRAs.
  • Prepare Physician Assessment Form and ensure that medical monitor assessments of SAE documents are completed and distributed according to project requirements.
  • Coordinate SAE activities for assigned projects, including study start-up, maintenance and close-out activities, SAE reconciliation, budget tracking and forecasting for assigned studies.
  • Produce and maintain accurate status and metric reports for assigned projects.
  • Prepare and QC patient SAE narratives.
  • Produce accurate SAE data for reporting purposes (including regulatory reporting).
  • Prepare and submit expedited safety reports and manage the reporting process.
  • Identify project resourcing needs.
  • Promptly advise the Manager/Associate Director/Director, Pharmacovigilance of any significant safety and regulatory concerns.
  • Develop and maintain a cooperative working relationship with project team members.
  • Attend and professionally represent PVG at team meetings, client meetings, and other appropriate meetings, as required, for assigned projects.
  • QC safety-related paper documents/electronic data/database entries prepared by others.
  • SAE reconciliation – Review Data Management listings, database reports, and validation checks
  • Adhere to corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs.
  • Adhere to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues.
  • Participate in internal training initiatives to keep up-to-date in safety regulations, processes, and company policy regarding Safety issues etc.
  • Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
  • Prepare and give presentations to client and/or project teams.
  • Coordinate sponsor, investigator and Data Monitoring Committee (DMC) meetings.
  • Perform internal audit activities for departmental processes and procedures.
  • Assist with external audit activities.
  • Provide input to SOP/WPD generation and revisions.
  • Exercise independent judgement to manage and resolve safety issues for standard non-complex projects, including PVG coordination of sponsor and investigator meetings, with minimal supervision.
  • Develop supervisory and mentoring skills for standard SAE processing, study set-up, maintenance, close-out and narrative generation.
  • Oversee and give direction to a project group/team.

 

As Pharmacovigilance Specialist, you will have the following qualifications and experience:

  • Bachelor’s degree in Life Sciences or Nursing
  • Proven medical/clinical experience or clinical/safety experience and SAE processing experience/or clinical safety experience
  • In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications

 

How to apply:

For more information or to apply for this Pharmacovigilance Specialist position, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL22783 in all correspondence.

Click here to search our current Pharmacovigilance jobs online now.

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