Associate Director Patient Safety Scientist

Role Summary

The Associate Director, Patient Safety Scientist leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. They author and lead PV input to safety documents and regulatory reports. The role also involves leading meetings and presenting safety data and analyses.

Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Qualifications

• A life sciences/pharmacy/nursing degree
• Demonstrated Patient Safety experience including:
• Clinical drug development (Early and/or Late Phase: program level safety strategy, including proactive risk identification & mitigation planning)
• Post-Marketing Surveillance (including signal detection & evaluation)
• Periodic Safety Reports (strategy, preparation and authoring)
• Risk Management Plans (strategy, preparation and authoring)
• Knowledge of pharmacovigilance regulation
• Fluent in written and verbal English
• Basic understanding of epidemiology