Associate Director, Senior Patient Safety Scientist
About The Position
The Associate Director, Senior Patient Safety Scientist leads the review of safety data and related documents to identify potential safety issues, in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. The role authors and leads pharmacovigilance input to safety documents and regulatory reports, leads meetings, and presents safety data and analyses. The position leads proactive pharmacovigilance and risk management planning for more complex products, including safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS). It provides safety expertise across clinical and regulatory documents, supports cross-functional project teams for developmental compounds and marketed products, and may lead Safety Strategy and Management Teams for larger or more complex projects. The role also contributes to safety committee reviews, reference safety information, periodic regulatory documents, regulatory submissions, third-party agreements, and the training and mentorship of junior team members.
Requirements
- A degree in life sciences, pharmacy, or nursing, and demonstrated Patient Safety and/or Clinical/Drug Development experience.
- Advanced knowledge of pharmacovigilance regulations.
- Substantial pharmaceutical, biotechnology, or CRO experience in patient safety/pharmacovigilance and drug development, including experience independently delivering safety-science activities.
- Experience in at least two of the following: clinical development safety; signal management; periodic safety reports; safety sections of protocols, Investigator Brochures, Informed Consent Forms, or Clinical Study Reports; regulatory responses.
- Good knowledge of US, EU, and UK pharmacovigilance regulations and ICH guidelines.
Nice To Haves
- MD, MSc, or PhD in a scientific discipline.
- Intermediate understanding of epidemiology.
Responsibilities
- Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of safety aspects of Global Risk Management Plans and REMS in partnership with the GSP and others as appropriate.
- Lead Patient Safety activities of cross-functional project teams for developmental compounds and/or marketed products.
- Lead and provide safety expertise for Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
- Perform duties as a Safety Strategy and Management Team Leader for larger or more complex projects.
- Present complex issues to the Safety Information Review Committee and lead data evaluation and discussion of results with the SIRC Chair, GSP, and other key stakeholders.
- Lead collaboration with the GSP and Clinical representatives and author Reference Safety Information for multiple or complex development products.
- Author or provide strategic input or oversight for multiple or complex periodic regulatory documents, including PBRERs, PSURs, and DSURs, according to agreed processes and timelines.
- Author or provide strategic leadership for regulatory submissions for new products, formulations, or indications, including NDA/BLA and MAA submissions, in partnership with the GSP and other functional experts.
- Participate in negotiations and provide expertise on the Patient Safety component of contracts or agreements with third parties to ensure their quality and integrity.
- Train and mentor junior team members in approved pharmacovigilance processes, analytic methodologies, and related areas.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
