(Sr) Pharmacovigilance Safety Director

Netherlands | Pharmacovigilance Safety Director | Drug Development | Drug Safety Science | Clinical | 1044310

Your new role
For our client we’re looking for a PV Safety Director who is supporting early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. You will bring safety expertise to interactions with internal stakeholders, Regulatory Authorities and Data Monitoring Committees. Your responsibilities are including but not limited to:

  • Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context;
  • Signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the review of safety assessments and drug safety reports for signals or issues or in response to Regulatory Authority requests
  • Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
  • Safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.)

What you'll need to succeed
To be successful in this role you hold a relevant postgraduate qualification such as MSc or PhD in Life Sciences and you’ve gained more than 6 years of drug development experience including at least 3 years in drug safety. We have 2 roles available as Director and Sr. Director. For the Senior director you’ll need at least 5+ years of experience in drug safety. You can demonstrate a strong expertise in drug safety and will be expected to work with minimal oversight and apply strong self-leadership. You have a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements). Ability to lead and influence, with and without authority, in a global matrix environment where you can interact effectively in a multifunctional and multicultural team setting. Last but not least, you have strong presentation, written and verbal communication skills.

Your new company
You’ll work for one of the biggest pharmaceutical companies in the world with a large drug product portfolio against diseases such as cancer, hemophilia, MS and rheumatoid arthritis. You’ll be part of a international team with colleagues working across Europe and in the US.

What you'll get in return
This is a contractor role for a period of at least 18 months where you can work fully remote. At this position, you will get a competitive salary which can be agreed with the client based on your experience and expertise. Full-time availability is strongly preferred. Visa sponsorship cannot be provided.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1044310
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Life Sciences
Can be discussed based on experience.

Spreek met een consultant

Spreek met Ricardo Vos, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telefoonnummer: 0615878909