Associate Director Medical Safety - 1yr contract - Netherlands

Reference: RS111220R

Expiry Date: 23-09-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Contractor

Location:
Leiden
Netherlands

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Job Description

Associate Director Medical Safety - 1yr contract - Netherlands

Global Pharmaceutical is seeking an AD Medical Safety to join a team of 4 working on a large complex marketed product. This role is 100% remote during covid conditions with a desire to reconvene at an office 1-2 days per week following.


Role

  • Responsible for providing medical safety leadership and direction to  Global TA colleagues and support to the Global TA Group Lead with regards to the design and successful implementation of medical safety strategies for drug products within the Global TA, 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 stakeholders in and outside MS and the PV organization.
  • Responsible and accountable for the risk management of assigned client 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.
  • 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 assigned Client 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.
  • As this position is expected to function autonomously, without a great deal of oversight from the (Medical) Director, assigned products may be those requiring more specialized expertise. Responsible and accountable for adequate benefit-risk assessments for assigned Client drug products within the Global TA. Inadequate benefit-risk assessments may have negative impact on product success, such as delays in regulatory authority approvals and imposition of restrictive labeling, and direct and consequential threat to the viability of drug applications for regulatory approval owing to medical safety strategy quality and standards weaknesses.

Experience

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

Please contact me now for interviews booked next week if interested.

To Apply!

To apply for this role, please send your CV to roland@advtalent.com, or contact me, Roland Schnapka, on +31 (0)71 203 2098 in full confidence to receive more details on this role or to hear about other available opportunities. Alternatively, please press the red “Apply for position” button and follow the registration process.

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