4 months ago
Our client is a global biopharmaceutical company who are focusing their efforts in developing products in both oncology and endocrinology. They are currently looking to find an experienced Pharmacovigilance Senior Director, to lead out its Safety Evaluation efforts at its Palo Alto location.
In this position, you will lead global safety evaluation in the analysis of safety data, identifying, detecting and investigating safety signals, evaluating and proactively managing risk, and providing medical safety review for the companies investigational compounds and market products. The role will provide medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events.
Main responsibilities include:
- Working closely with the PV operations team and to participate in the planning, designing and support of all US pharmacovigilance operation activities related to enable US product launch activities.
- Managing on-going product safety as part of the safety governance process.
- Participating in Patient Safety Team and Corporate Safety Board activities.
- Implementing proactive safety analysis strategies to further define the product safety profile.
- To contribute to safety sections of clinical investigator brochures, risk profiles, protocols, labels and regulatory reports with a focus on providing an overview for the medical analysis and safety sections.
- Ensures compliance with US and international pharmacovigilance regulations.
- An MD (Doctor of Medicine) certification is MUST
- 5+ years of experience in pharmacovigilance gained in pharmaceutical industry.
- Management experience in Pharmacovigilance or Drug Safety.
- In depth clinical and Pharmacoepidemiology experience is a MUST.
- Strategic proficiency in crafting approach to relevant FDA, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICHGCP/CIOMS best practices).
If this opportunity interests you, please get in touch today so that we can provide a full job description and explore in more detail!