Posted in Industry News, News
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.
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
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
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
Please contact Hendre for more details.
How to apply:
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 email@example.com. Please quote reference CL25881 in all correspondence.
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Posted in Featured Jobs, News
Posted in Featured Jobs, News
Here is a list of the latest pharmaceutical jobs which CK Clinical is recruiting for in the UK and Europe. Please click on the links below to find out more and apply.
Regulatory Affairs Jobs
Medical Information Jobs
Drug Safety Jobs
Posted in Industry News, News, Uncategorized
Novartis has agreed to buy specialty dermatology generics company Fougera Pharmaceuticals for USD 1.525 billion.
Fougera is a specialty dermatology business with 2011 net sales of USD 429 million, and employs 700 people across its two primary sites, located in New York
The agreement will create a strong global growth platform for Sandoz, which is the pharmaceuticals division of Novartis. Sandoz will use its leading position both in the US generics sector and its presence in over 130 countries worldwide to expand Fougera’s existing sales base and bring its broad dermatology portfolio to new markets around the world.
Jeff George, Global Head of Sandoz said “The addition of Fougera’s leading portfolio further strengthens Sandoz’s differentiated products strategy and improves our ability to help patients and customers around the world by providing easier access to high quality, affordable dermatological medicines. Fougera brings us valuable technical capabilities in the area of topical dermatological products, particularly in the development and manufacturing of semi-solid forms such as creams and ointments,”
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Posted in Industry News, News
CK Clinical, a leading Pharmaceutical recruitment consultancy have interviewed a number of professionals currently working in the Pharmaceutical Industry.
So, if you are interested in working in the Pharmaceutical Industry or are looking to change career paths within the industry, please click on the links below to find out what’s like to work within these various disciplines:
Click here to register your CV with us.
Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any pharmaceutical jobs which may be of interest to you.
Click here to search and apply for our current Pharmaceutical jobs in the UK and EU.
For more information regarding jobs in the UK and EU Pharmaceutical Industry, please contact CK Clinical on +44 (0)1438 743 047 or email firstname.lastname@example.org.
Posted in Featured Jobs, News
Krishna Pankhania at CK Clinical is currently recruiting for a Pharmacovigilance Manager to join a pharmaceutical company based in Hertfordshire, UK.
As Pharmacovigilance Manager, you will be part of a medium sized team and will act as the direct report to the team. Further responsibilities will include:
- Communication with clients, regulatory authorities, ethics committees, investigational sitesand reporters and other client service providers.
- Ensure client and patient confidentiality is maintained.
- Operating at all times according to the appropriate SOP/procedural document.
- Prioritisation of activities to meet departmental, client and regulatory time-lines.
- Escalation of any issues that may impact on quality or compliance to the Pharmacovigilance Management Group and/or Manager Director.
- Maintaining awareness of current and potential guidelines/legislation on pharmacovigilance and related matters, clinical trial guidelines and other relevant topics.
- Maintain an accurate record of expenditure on external services.
- Maintain a time sheet to accurately record time spent on client and departmental projects.
- Any other reasonable task as requested by the Pharmacovigilance Management Group or Managing Director.
- To act as back up to other members of the Pharmacovigilance Management Team when required.
- Responsible for line management of direct reports.
- Responsible for ensuring efficient and effective appropriate use of departmental resources.
- Assists in financial forecasting and managing project level budgets.
- Responsible for ensuring contract deliverables are met for all projects managed by direct reports.
- Acting as part of the PV Management group, to ensure all services undertaken by Pharmacovigilance Department are run in adherence with applicable legislation and to quality standards.
- Proactive and structured management of the PV department workload to ensure regulatory compliance and quality standards are upheld.
- Working flexibly with colleagues to ensure PV deliverables can be met.
- Anticipates, plans and prioritises activities in support of meeting project deliverables.
- Holding staff appraisals and 121 meetings.
- Working with staff to create training and development plans and regularly reviewing progress.
- Working with direct reports to develop objectives and regular review of progress.
- Recruitment and retention of high quality staff.
- Responsible for prompt escalation of issues and assists in resolution (personnel, resourcing, departmental, client, authority or other party).
- Facilitates preparation and participation in internal audits and inspections.
- Contributing to, approval and implementation of CAPAs arising from inspections, external audits and internal audits.
- Assists in development and implementation of a training system across PV.
- Ensures back ups are in place to ensure smooth running of the department at all times.
- Identifies need for new resource and communicates business case to Director PV.
- Is accountable for delegation of tasks.
- Encourages efficiency and effectiveness in solutions.
The ideal candidate:
- Life Science degree or similar experience gained in Pharmaceutical Industry.
- Extensive experience in PV across ICSR management, aggregate report writing and inspection preparation and participation.
- Good knowledge of PV regulations EU and USA.
- Experience of line management required.
- Good leadership skills.
- Ability to work under pressure.
- Proactive approach to work.
- Project Management skills and ability to structure plans and ensure implementation.
- Good Team worker.
- Good organisational skills.
- Strong communication skills both verbal and written.
- Ability to negotiate and influence.
How to apply:
For more information or to apply for this Pharmacovigilance Manager please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email email@example.com. Please quote reference CL22897 in all correspondence.
Posted in Featured Jobs
Krishna, our specialist Medical Information. Drug Safety and PV Consultant, is currently handling two positions which she would like to tell you more about. Please see below for Krishna’s video explaining these roles. The positions are as follows:
A company in Berkshire are recruiting for a principle Medical information Scientist/ Pharmacist. The successful candidate will be able to provide Medical/Scientific Information provision to support.
A company in Hertfordshire is recruiting on a contract basis for a medical Writer in Pharmacovigilance. The successful candidate will be part of the Safety documentation team and will be responsible for preparation of Safety Reports, Six-Monthly SUSAR Reports and Risk Management Plans, including co-ordination, authoring and quality control.
Posted in Featured Jobs
A global pharmaceutical company are looking for a Senior Pharmacovigilance Specialist to join their team based in Hertfordshire, UK.
As a Senior Pharmacovigilance Specialist, you will be responsible for case management activities for Post marketing and Investigational products. In the absence of the Pharmacovigilance Country Lead, you will be responsible for overseeing and managing the day-to-day activities of the local country operations Pharmacovigilance Department.
Further responsibilities will include:
- Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry centre or contractual partners
- Conduct reconciliation of adverse events reports received from other company operating units and contractual partners, as applicable
- Submit, as applicable, spontaneous and solicited / clinical trial individual case safety reports (ICSRs) from their country/territories to the local Health Authorities
- File, store, and archive safety-related data
- Serves as back-up coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity
- Serves as the local Deputy Qualified Person for PV for their country in the absence of the local Qualified Person for PV when delegated
- Comply with PV regulations and Global Safety policies/procedures and when needed take corrective action
- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
- Prepare for audits/inspections for their country/territories and participates in the audit and/or inspection
- Identify and communicate potential safety issues
- Deliver training to PV staff and customer facing non-PV staff and distributors
- Train and mentor PV staff
- Complete and document required PV training within required timelines
- Serve as the point of contact for the local Health Authority or liaise with the Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in absence of the Pharmacovigilance Country Lead
- Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure processes are in place for activities that are performed by those functions which impact PV
- Liaise with the EU QP PV in consultation with Global Safety Regional Leader or Global Safety MoW / EU – Leader in the absence of the Pharmacovigilance Country Lead
- Liaise with PV Regional Centers/Data Management Centres
- Participate on corporate sponsored committees and councils in the absence of the Pharmacovigilance Country Lead
- Represent the company at external safety meetings
Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a Competitive rate.
Qualifications & Experience:
The ideal candidate for this Senior Pharmacovigilance Specialist will have the following qualifications and experience:
- The incumbent must have a health, life science, or medical science degree or equivalent by experience and be fluent in English while proficient in local language.
- He/she should have proven industry experience in pharmacovigilance.
- The Senior Pharmacovigilance Specialist must have extensive knowledge of Pharmacovigilance regulations in their country/territory.
- He/She is expected to have strong communication and time management skills and have the ability to work independently with minimal supervision.
For more information or to apply for this Senior Pharmacovigilance Specialist position, please contact Hendre on 01438 870 023 or email firstname.lastname@example.org. Please quote reference 21982 in all correspondence.
Posted in Featured Jobs
A leading pharmaceutical company in Hertfordshire are recruiting for a Safety Documentation Team Manager in Drug Safety for a 12 month fixed term contract.
As well as managing a team of Regulatory Documentation Associates and Scientists, as Safety Documentation Team Manager, you will be responsible for training, mentoring and coaching while providing a supportive environment for direct reports.
In addition, your performance management responsibilities will include goal setting and providing feedback to direct reports on their individual performance. In addition to taking on the job responsibilities of your direct reports when necessary.
The successful candidate for this Safety Documentation Team Manager job must have strong line-management and proven people management experience. In addition, they must also have the following skills and experience:
- PhD, MSc or equivalent in relevant scientific discipline
- Line management experience is essential
- Good problem solving skills
- Relevant Pharmaceutical experience or healthcare professional
- Strong people management skills
For more information or to apply for this Safety Documentation Team Manager position, please contact Hendre Moolman on 01843 743 047 or email email@example.com. Please quote reference CL21820 in all correspondence.