Meet up with Hendre at MSLA today

Hendre Moolman is attending the Third Annual MSLA Conference today at the Park Inn Heathrow at Heathrow airport. The theme of the conference is “MSLs Sharing and Learning Together”

The conference is intended to be a stimulating mix of keynote speakers, panel sessions, interactive workshops and plenty of time for networking. The topics presented will be of interest to all MSLs irrespective of Company, experience and therapy interests.

Hendre will be at the event all day today so if you would like to meet up with him contact him here

 

Find out more about the event here

 

 

 

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Pharmacovigilance Manager – London

Hendre Moolman at CK Clinical is recruiting for a Pharmacovigilance Manager to join a company in the pharmaceutical industry in a permanent role in the South East.

Responsibilities

As Pharmacovigilance Manager you will be responsible for the documentation and processing of adverse drug reactions reports.

Further responsibilities of this Pharmacovigilance Manager position will include:

  • The documentation and processing of reports of adverse drug reactions.
  • Expedited reporting of adverse drug reactions to EEA competent authorities, including reporting via EudraVigilance
  • Routine searches and evaluation of published medical and scientific literature for identification of individual case safety reports (ICSRs) and drug safety data
  • Preparation of PSURs
  • Preparation and maintenance of Risk Management Plans (RMPs) for clients
  • Undertaking signal management activities
  • Liaising with clients regarding their requirements for handling of adverse reactions, including registration with EudraVigilance

 Qualifications

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

  • Solid pharmacovigilance experience
  • Degree in life sciences discipline / background in nursing
  • Excellent understanding of medical terminology.
  • Experience in the interpretation of medical and scientific literature.
  • Experience in searching medical literature databases (e.g. PubMed)
  • Computer literate (primarily Word, Excel, Power Point)
  • Basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
  • Excellent written and verbal communication skills.
  • Excellent interpersonal skills with the ability to work with a number of different clients according to their various
  • requirements.
  • Good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements.
  • Well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment.
  • Car driver essential due to location

Desirable but not essential:

  • Experience/knowledge of the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
  • Experience in the submission and maintenance of products in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Experience in the participation of pharmacovigilance inspections

Benefits

As Pharmacovigilance Manager 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
  • Permanent roleHendre Moolman - Pharmacovigilance Recruitment

How to apply

For more information or to apply for this Pharmacovigilance Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk.  Please quote reference CL25912 in all correspondence.

Are you looking for a job as a Pharmacovigilance Manager?

Click here to view CK Science Pharmacovigilance Manager jobs 

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Drug Safety Manager Job – Surrey, UK

 An established pharmaceutical company is looking for a Drug Safety Manager to join their team based in Surrey, UK.

 

Responsibilities:

As Drug Safety Manager, your main role will be to work on the review, analysis, preparation and completion of reports of adverse drug experience to determine the safety profile of the company products. You will need to manage resources in the safety team depending on local organisation and safety group size.

Further key responsibilities of this role will include:

  • Organise and manage local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
  • Manage, where applicable, safety resources in the local team
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
  • Ensure complete and timely submission of ICSR to the Core workflow
  • Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
  • Determine if appropriate case follow-up has been considered
  • Consistently apply regulatory requirements and company policies
  • Analyse and monitor activities, define and implement corrective actions, where applicable.
  • Develop and maintain expertise with advanced knowledge of all assigned products, of applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
  • Provide oversight and team monitoring on case handling aspects, data extraction, and analyses
  • Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across all SRM DSU
  • Act as subject matter expert for SRM DSU within SRM
  • Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety dada collection and handling

 

Qualifications and Experience:

The ideal candidate for this Drug Safety Manager position will have the following qualifications and experience:

  • Ability to independently solve routine problems related to case processing and surface issues constructively
  • Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
  • Experience in Pharmacovigilance required
  • Solid working knowledge of pharmaceutical concepts
  • Understanding and ability to use computer technology, management of relational database systems (specifically ARGUS), including extraction of data
  • Strong skills in productivity, organisational and time management in order to meet strict regulatory compliance goals
  • Excellent understanding of medical terminology
  • Knowledge of global regulations and guidelines for drug development and post marketing activities
  • Ability to work independently to accomplish team goals with minimal supervision<p>
  • Demonstrated ability to foster teamwork
  • Experience of managing technical staff

 

 Apply Now

For more information, or to apply for this Drug Safety Manager position, please contact Hendre Moolman at CK Clinical on Tel: +44 (0)1438 870 023 or email hmoolman@ckclinical.co.uk quoting 20623 to indicate your interest.

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Manager of Drug Safety Services Job – West Sussex

An established CRO based in West Sussex, are currently looking for a Manager of Drug Safety Services to join their team.

 

Responsibilities:

As Manager of Drug Safety Services, you will be required to to line manage a team of associates and lead global projects. Part of your position will require you to contribute to the Quality aspects of the team’s output.

Further key responsibilities of this Manager of Drug Safety position, will include:

  • Line management of Drug Safety Associates and project management of case loads
  • Interact and influence line and middle management, staff and external contacts on a functional and tactical level
  • Work collaboratively with Safety Management’s team
  • Ensure client and global regulatory compliance
  • Present and share useful business information across departments and functions
  • Anticipate/identify problems and takes appropriate action to correct
  • Maintain an up to date knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
  • Maintain a good awareness of the regulatory environment regarding Risk Management and Pharmacovigilance

 

Benefits

Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE SALARY, HOLIDAYS, and CAREER PROGRESSION.

 

 Qualifications, Skills and Experience

The ideal candidate for this Manager of Drug Safety Services position will have experience in safety surveillance; case management and knowledge of Periodic Safety Update Reports are desirable.

 

In addition the following skills and experience are required:

  • You should be working in a supervisory capacity in a Drug Safety environment
  • Have worked in safety surveillance and case management
  • And worked in a European or global environment
  • Knowledge of Medical Device Reporting desirable
  • Knowledge of Periodic Safety Update Reports (PSUR) desirable
  • You should be a science graduate with at proven experience in Pharmacovigilance.
  • Experience in scientific review of documents and writing of aggregate safety reports is essential.
  • Proven experience of mentoring / direct report responsibility is required.
  • Effective communicator both in writing and verbally
  • Excellent interpersonal skills
  • Able to operate as a flexible team player

 

 Apply Now

For more information, or to apply for this Manager of Drug Safety Services position, please contact Hendre Moolman at CK Clinical on +44 (0)1438 743047 or email hmoolman@ckclinical.co.uk quoting 20582 to indicate your interest.

 

Alternatively, click here to apply for this Manager of Drug Safety Services position online now.

 

Not quite what you’re looking for? Click here to search our current Drug Safety jobs online now. 

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Drug Safety Manager Job – Surrey, UK

A Drug Safety Manager is required to join an established pharmaceutical company based in Surrey, UK.


In this position you will work on the review, analysis, preparation and completion of reports of adverse drug experience to determine the safety profile of the company products. As Drug Safety Manager, you will need to manage resources in the safety team depending on local organisation and safety group size.

Key Responsibilities:

Further key responsibilities of this Drug Safety Manager position will include:

  • Organising and managing local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
  • Managing, where applicable, safety resources in the local team.
  • Ensuring regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
  • Ensuring complete and timely submission of ICSR to the Core workflow.
  • Reviewing processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.
  • Determining if appropriate case follow-up has been considered.
  • Consistently apply regulatory requirements and company policies.
  • Analysing and monitoring activities, defining and implementing corrective actions, where applicable.
  • Developing and maintaining expertise with advanced knowledge of all assigned products, of applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practises, of data entry conventions, and of search functions in the safety database.
  • Providing oversight and team monitoring on case handling aspects, data extraction, and analyses.
  • Leveraging and applying required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across all SRM DSU.
  • Acting as subject matter expert for SRM DSU within SRM.
  • Acting as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling.

Qualifications and Experience:

The ideal candidate for this Drug Safety Manager position will have the following qualifications and experience:

  • Ability to independently solve routine problems related to case processing and surface issues constructively.
  • Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact.
  • Experience in Pharmacovigilance required.
  • Solid working knowledge of pharmaceutical concepts.
  • Understanding and ability to use computer technology, management of relational database systems (specifically ARGUS), including extraction of data.
  • Strong skills in productivity, organisational and time management in order to meet strict regulatory compliance goals.
  • Excellent understanding of medical terminology.
  • Knowledge of global regulations and guidelines for drug development and post marketing activities.
  • Ability to work independently to accomplish team goals with minimal supervision.
  • Demonstrated ability to foster teamwork.
  • Experience of managing technical staff.

Apply Now

For more information or to apply for this Drug Safety Manager position, please contact Hendre on Tel: +44 (0)1438 870 023 or email me at hmoolman@ckclinical.co.uk quoting 20623 to indicate your interest.

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Pharmacovigilance Manager Job

We are currnely recruiting for Pharmacovigilance Manager.

Background

We are currently recruiting for a Manager of Pharmacovigilance with a very dynamic consultancy. This is an exciting opportunity to set up and lead a new Pharmacovigilance department. You will be responsible for providing leadership in all Pharmacovigilance matters, training drug safety people internally, and acting as the main point of contact for clients relating to Pharmacovigilance matters and implementing SOPs. There is potential to move to a Directorship role, with shares in the business and potential to be trained as a QP.

Key responsibilities

– Running the Drug Safety team on a day-to-day basis.

– Provide leadership and training in all pharmacovigilance matters.

– Allocation of work to relevant team members.

Your supervisory responsibilities will include:

– Leading and training other members of the team in the Grantham office.

– As additional team members join also responsible for managing them.

– Help manage department growth and assist in the managing the department’s budget.

The Day to day duties of the role:

– Point of contact for clients relating to pharmacovigilance matters

– Training other team members

– Managing case load

– PSUR writing as required

– SAE narrative writing asrequired

– To perform SAE reconciliation

– Good awareness and knowledge of ABPI code of practice and its application

– Triage in-coming Pharmacovigilance reports in accordance to their seriousness and regulatory context

– To perform^follow-up activities for Pharmacovigilance Reports

– Ensures all projects meet targets and deadlines

– Ensuring procedures are in place and are followed

– Signal generation.

– To ensure that such activities are performed to high standards of quality and timeliness in line with the best industry standards.

– Compliance to SOP’s, processes, practices and guidelines

Training and development

There is the potential to move into a Directorship role with Shares in the business. Potential to be trained as a QP

Qualifications:

– Life science or

– Technically competent in performing similar function in either a Pharmaceutical or CRO environment

– Good written and verbal communication

– Ability to prioritise workloads and to negotiate and meet deadlines

– Commercial awareness

– Customer focused

– Team player

– Flexible approach

To Apply

If you expect more than just a great salary and benefits package and believe you can make an impact in this innovative and cutting edge business, then please contact Hendre on Tel: +44 (0)1438 743047 or email me at hmoolman@cklinical.co.uk quoting reference 16613.

Not quite what you are looking for? Click here to search for other jobs in Pharmacovigilance now.

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