Sr. Director, Pharmacovigilance Safety Science (Remote)
Are you looking to join clinical stage biotech company, want the stability that a larger pharma company can provide? Well no look further. We have partnered with a clinical stage Cardiology company that is a wholly owned subsidiary of one of the largest and most prestigious biopharmaceutical organizations in its search for a Sr. Director, Pharmacovigilance Safety Science (Remote). This company is open to individuals who don't have leadership experience if they are open to being considered at the director level.
The Sr. Director, Pharmacovigilance Safety Science (Remote) will be responsible for:
- For company products (whether in Clinical development or Post marketing), take medical responsibility in safety data monitoring and analysis, signal detection and evaluation and decision-making regarding the reporting and communication of newly identified safety concerns both internally and externally. Work strategically and collaboratively to assess the impact of safety concerns on usage of the product.
- Author the product's Product Safety Plan commensurate with the stage of development/product lifecycle
- Review clinical study protocols, protocol amendments, CDRPs, investigator's brochures, clinical study reports, statistical analysis plans and similar documents with significant safety components
- Work collaboratively with scientists in PV Operations to assist in decisions related to management of clinical trials (need for specialized CRFs, determination of AESIs, investigator training and site education, etc.)
- Contribute to the development of risk mitigation and management strategies throughout a product's lifecycle as well as creation of a product's Risk Management Plan (when required).
- Provide safety contributions to key regulatory documents (INDs, IBs, Briefing documents, DSUR), clinical study reports and statistical analysis plans
- Contribute/lead the strategy and analysis for DSURs, PADERs and PSURs
- In conjunction with epidemiologists/data scientists develop an epidemiologic plan to contextualize the disease state and its inherent risks to both support the assessment of safety signals as well as authorship of risk management plans, when required.
- Collaborate with research, translational research, medical affairs, and biometrics on cross-functional initiatives
- Work collaboratively with Head of Safety Operations to enhance data quality and data integrity
- Due diligence experienced desirable
Ideal Candidates will have:
- MD., or foreign equivalent.
- Minimum 3-4 years pharmacovigilance experience working in the regulated medical products industry with a strong track record in working well with teams.
- Experience in monitoring patient safety in a Phase 3 program is required and experience with an NDA filing is a plus.
- Experience in signal detection and risk management required.