Associate Director Medical Safety

Location
Leiden
Salary
Negotiable
Posted
Jan 08, 2021
Closes
Feb 07, 2021
Ref
ST274965/01
Contact
Sofie Thijs
Organization Type
Corporate
Contract Type
Temporary/Locum
Hours
Full Time

My client, one of the largest bio-pharmaceutical companies in the world, is looking for an Associate Director Medical Safety who can provide medical safety leadership and direction to Urology & Nephrology colleagues and support to the Global Therapeutic Area Group Lead with regards to the design and successful implementation of medical safety strategies for drug products by authorizing, reviewing and, as appropriate, approving medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stakeholders in and outside MS and the PV organization.

As Associate Director Medical Safety you will reports to the Medical Director/ Director. You will be a member of the Global Therapeutic Area and assists in ensuring the effective translation and execution of the Global TA operating plan such that Global TA, Medical Safety (MS), and Pharmacovigilance (PV) strategic goals are achieved.

Main responsibilities:

  • Accountable for the risk management of assigned drug products, both those in development and marketed 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 Safety Science.

  • 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.

  • Accountable for the ongoing monitoring and assessment of the safety profile of assigned developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 - Phase 3 clinical trials and Post-Authorization Studies.

What we are looking for :

  • Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred; or M.D. or D.O. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).

  • Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor's or master's degree, in the pharmaceutical industry in the area of pharmacovigilance, more specifically within medical safety science functions.

  • Direct exposure to pharmacovigilance functions is a must; additional regulatory and/or clinical development experience is a plus.

  • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.

  • Demonstrated capabilities in independently conducting complex analyses and working with large datasets.

  • Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.

  • Pharmaceutical industry experience in a relevant therapeutic area, i.e. transplant, strongly preferred.

  • Fluent in English, both written and verbal.

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!

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