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Associate Medical Safety Director

2019-02-01 CLS Services | Leiden | WO / MBA | Fulltime | Sluit 2019-04-02

As Associate Medical Director Safety, you will be the Product Responsible Person (PRP) for Medical Safety Activities and you will be involved in Strategy Development and Execution. Your responsibilities are: Medical Safety Activities Product Responsible Person (PRP): - Responsible and ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for an Associate Medical Safety Director .

Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, and Oncology. In the Netherlands Astellas is located in Leiden and Meppel.



Job description
As Associate Medical Director Safety, you will be the Product Responsible Person (PRP) for Medical Safety Activities and you will be involved in Strategy Development and Execution. Your responsibilities are:

Medical Safety Activities Product Responsible Person (PRP):

  • Responsible and accountable for the co-ordination and medical-scientific monitoring and assessment of the safety profile of one or more specific products;
  • Leading GPV (Global PV) Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies;
  • Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labelling. This also includes responsibility for effective and regular communication with the Global TA (Therapeutic Area) Group Lead and with the applicable QPPV;
  • Responsible and accountable for the design of safety surveillance strategies, management of safety signals for drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorisation and prioritisation of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Global Safety Science;
  • Responsible and accountable for the risk management of drug products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Global Safety Science;
  • Responsible and accountable for timely and high quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical - scientific analyses and conclusions;
  • Responsible and accountable for the ongoing monitoring and assessment of the safety profile of developmental and marketed products as a member of study teams and for representing GPV in the design, conduct, analysis and reporting of Phase 1– Phase 3 clinical trials and Post-Authorisation Studies.


Strategy Development and Execution:
  • Support the Global TA Group Lead, and, as appropriate (Medical) Director in the identification, development, implementation and communication of process improvements tools, systems and procedures within GMS to ensure efficiency and consistency in safety surveillance;
  • Support the Global TA Group Lead, and, as appropriate (Medical) Director in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans, ensuring feasibility and global alignment in collaboration with the GMS Leadership team.


Who we're looking for
The ideal candidate has a PharmD, M.D. or PhD with at least 6 years of pharmaceutical industry experience with direct exposure to pharmacovigilance functions. You have specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports. Additional regulatory and/or clinical development experience is a plus.
You have in-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, able to influence decisions relating to patient safety and assessment of benefit - risk.
You have excellent communication and presentation skills in English. In addition, strong interpersonal skills are required, with experience with working with people from different cultures (US/Japan) and a demonstrated ability to handle conflict situations.
Do you have experience in planning, allocating and managing multiple projects and demonstrated leadership capabilities? Then we are looking for you!

Additional vacancy information
Reference: A1900011
Contract: Temporary contract with CLS Services
Education: WO/MSc.
PhD.
Terms: Project for at least 1 year, some travelling required.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555



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