Senior Director, Global Patient Safety - General Medicine

Role Summary

Senior Director, Global Patient Safety – General Medicine. Leads GPS activities for assigned obesity/metabolism compounds across the asset lifecycle, including safety surveillance, signal management, and communication of the safety profile. Represents GPS on cross-functional teams as the SMT chair and GPS lead for safety strategy, coordinating with stakeholders to deliver the safety profile and strategy. This role requires the ability to influence colleagues in a matrix environment, including senior management.

Responsibilities

• Serve as the first point of contact for all safety-related issues for the compound(s) assigned within the therapeutic area.
• Directly responsible for all aspects of GPS activities for assigned compounds, including safety surveillance, signal management, communication of the safety profile, benefit-risk assessment, safety responses to regulatory queries, safety documents (DSURs, PSURs, development RMPS/RMPs), and review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.).
• Represent GPS on the cross-functional Strategic Program Team (SPT) and chair the Safety Management Team (SMT) for the compound.
• Lead the safety strategy and secure optimal support from GPS, collaborating with stakeholders to deliver the safety profile and the safety strategy.
• Work with assigned compounds that include obesity/metabolism products in various stages of development.
• Operate effectively in a matrix environment and influence colleagues, including senior management, within GPS and external to GPS.

Qualifications

• Required: 5+ years of total relevant experience in Pharmacovigilance and/or a relevant medical field with a PharmD, PhD, or MD degree.
• Required: 15+ years of total relevant experience in PV and/or relevant medical field or equivalent industry experience in drug safety, including significant experience with PSURs/DSURs/(d)RMPS; or in clinical development with demonstrated achievements in safety (e.g., supporting an ISS; responsible for CSR content).
• Required: Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices.
• Required: Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
• Required: Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.
• Required: Thorough understanding of drug development and context as applicable to safety surveillance activities.
• Required: A proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment.
• Required: An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.
• Required: Ability to utilize GPS safety database for purposes of medical case review and simple queries.
• Preferred: Mentoring junior safety scientists and cultivating cross-functional relationships and continuous improvement within the GPS organization.

Skills

• Safety surveillance and signal management
• Regulatory knowledge (FDA, EU, ICH) and pharmacovigilance practices in clinical and post-marketing contexts
• Cross-functional leadership and matrix collaboration
• Medical review of complex ICSRs and other data sources
• Development and maintenance of SOPs, working practices, and guides
• Continuous improvement and relationship building across therapeutic areas
• Database querying and data interpretation for safety reviews

Education

• Required: PharmD, PhD, or MD degree.