Associate Director Medical Safety
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 Director Medical Safety.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. 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, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Are you a physician, experienced in Pharmacovigilance and medical safety? Do you like to continue learning and working in a large international pharmaceutical company? We are looking for an Associate Director Medical Safety at Astellas!
In your role, you are responsible for providing medical safety leadership and direction to Global TA colleagues and support to the Global TA Group Lead with regard to the design and successful implementation of medical safety strategies for Tacrolimus, by authoring, reviewing and, as appropriate, approving medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stake holders.
You act as a product responsible person (PRP) for proactive safety surveillance of Tacrolimus, including leading PV Product Responsible Teams. As a pharmacovigilance specialist, you are responsible for ensuring the medical safety for Tacrolimus, contributing to an optimal benefit/risk profile and for the design and successful implementation of signal management and risk management strategies.
- Responsible and accountable for the co-ordination and medical-scientific monitoring and assessment of the safety profile of Tacrolimus;
- Lead PV Product Responsible Teams for Tacrolimus, co-chair Global Development Safety Management Teams, and participate in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of Tacrolimus and contributing to an optimal benefit-risk profile;
- Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates;
- Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Tacrolimus;
- Responsible and accountable for the risk management of Tacrolimus, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stake holders, working closely with Safety Science;
- Responsible and accountable for contribution to periodic and safety reports for Tacrolimus 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 Tacrolimus as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Post-Authorisation Studies;
- Support the Global TA Group Lead in the identification, development, implementation and communication of process improvements tools, systems and procedures;
- Support the Global TA Group Lead 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;
- Responsible and accountable for adequate benefit-risk assessments for Tacrolimus.
Who we're looking for
The ideal candidate for this position is a physician with at least 6-8 years experience in pharmaceutical industry, preferably in the field of transplantation. You have experience in pharmacovigilance function, additional regulatory and/or clinical development experience is a plus. We are looking for someone with excellent communication, writing skills and hands-on excel experience.
- Experience with Argus and Empirica;
- Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stake holders;
- 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;
- Specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports;
- Experience in planning, allocating and managing multiple projects;
- Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus, and understand differences in both regulations and cultures.
Are you the experienced candidate we are looking for?
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least one year. Mostly home-based, expected to be in Leiden a few days per month.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555