Associate Director Medical Safety

  • Leiden
  • 5000.00 - 6500.00
  • 32-40 uren
  • WO

Opdrachtgever

Our client is a consultancy in the food and pharmaceutical industry.

Opdrachtgever

Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.

functie Vereisten

Professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred; or M.D. or D.O. strongly preferred (certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
Pharmaceutical industry experience in a relevant therapeutic area.
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.
Experience in planning, allocating and managing multiple projects.
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.
Ability to work within a matrix environment.
Strong skills in Excel and Word.
Strong skills in scientific writing.
Fluent in English, both written and verbal.

Wat krijg je?

  • Pensioenopbouw vanaf de eerste dag
  • Collectieve WGA/WIA verzekering
  • NBBU/ABU cao
  • 25 vakantiedagen
  • 8,33% vakantiegeld
  • 100% doorbetaling bij ziekte na één wachtdag
  • Reiskostenvergoeding

Werkzaamheden

Responsible for providing medical safety leadership and direction to Therapeutic Area colleagues and support to the Group Lead with regards to the design and successful implementation of medical safety strategies for drug products Authoring, reviewing and approving medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stakeholders.
Responsible and accountable for the risk management of assigned 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 Safety Science.

TAGCLOUD

Medical, safety, drug, scientific
Peter Debrichy

Geïnteresseerd?

Stuur uw cv naar peter@tailorminds.com onder vermelding van vacature id (807)

Meer informatie?

Neem contact op met Peter Debrichy van ons kantoor te Zoetermeer, te bereiken op nummer +31 6-10191580

SOLLICITEER MET ONDERSTAAND FORMULIER

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