Medical Safety Lead

Responsibilities

• Provide strategic medical safety leadership and practical contributions in a cross-functional setting
• Participate in cross-functional strategic planning and meetings
• Lead and contribute to the safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews
• Contribute to the development of the overall safety governance structure and activities
• Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, responses to regulatory authority inquiries)
• Contribute to and ensure completeness, accuracy and high quality safety sections of clinical documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
• Perform the medical assessment of individual case safety reports (ICSR) when required
• Provide medical safety contributions at internal audits and regulatory inspections
• Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support product(s) safety training and pharmacovigilance awareness activities cross functionally
• Lead the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
• Contribute actively to the updates of the safety labelling sections and Core Data Sheets (CDS)
• Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention
• Participate in cross-functional projects and initiatives
• Manage safety physicians as required
• Perform other tasks as required to assist in departmental activities

Requirements

MD degree or equivalent required

At least 10 years of relevant experience in the pharmaceutical/biotech industry with at least 7 years in pharmacovigilance/drug safety (global experience is a plus)

Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines) and managing complex matrix teams

Experience in clinical practice or in academic medicine is a plus

Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents

Demonstrated ability to perform medical assessments of safety data from multiple sources

Experience with authoring complex documents and contributing to regulatory submissions

Knowledge of adverse event reporting systems

Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus