Senior Manager, Pharmacovigilance Scientist

Location of role Gaithersburg, MD, Radnor, PA, Oxford, UK Department Regulatory Affairs Key Responsibilities The Senior Manager, Pharmacovigilance Scientist applies broad expertise in pharmacovigilance and related activities for assigned development and marketed products throughout the product lifecycle. The role is responsible for leading product-level safety surveillance, signal management, benefit-risk evaluation, aggregate safety reporting, and risk management planning while ensuring compliance with global pharmacovigilance regulations and company procedures. The Senior Manager addresses safety problems that require evaluating variables and integrating data from multiple clinical, nonclinical, and post-marketing areas. The individual determines the methodology used for safety analyses, exercises independent judgment in developing methods and evaluation criteria, and serves as a best-practice resource within Global Patient Safety. Working collaboratively with Safety Physicians and Pharmacovigilance Operations, the Senior Manager contributes directly to the development of pharmacovigilance strategy within their area, drives the safety strategy of larger cross-functional projects, and represents the function in interactions with cross-functional project teams, safety governance committees, and executive-level colleagues. The individual may lead functional project teams and may directly oversee external vendors in the Safety Sciences area. Key Responsibilities Lead safety surveillance for assigned investigational and/or marketed products. Lead signal detection, evaluation, documentation, communication, and closure in accordance with Immunocore procedures and global regulatory requirements. Integrate and interpret safety data from clinical trials, individual case safety reports, literature, aggregate analyses, and other relevant sources. Lead benefit-risk assessments and communicate recommendations to Safety Management Teams and governance bodies. Escalate emerging safety issues and potential risks to appropriate senior stakeholders. Lead the planning, authoring, review, and timely delivery of aggregate safety reports, including DSURs, PBRERs/PSURs, and PADERs, as applicable. Lead or review key safety documents, including Investigator Brochures, Reference Safety Information, Risk Management Plans, and safety sections of regulatory submissions. Ensure safety documentation is scientifically rigorous, consistent, and compliant with global regulatory requirements. Establish and manage timelines, cross-functional review processes, and quality standards for assigned deliverables Lead development and maintenance of product-specific pharmacovigilance plans and Risk Management Plans. Evaluate risk-minimization measures and post-authorization safety commitments. Provide pharmacovigilance input to clinical development, protocol design, safety monitoring, labeling, and lifecycle-management activities. Partner with Regulatory Affairs and Medical Affairs to ensure consistent safety messaging. Represent Pharmacovigilance on program teams, governance forums, and relevant internal and external meetings. Coordinate work performed by assigned cross-functional contributors, contractors, consultants, or vendors. Maintain compliance with applicable global pharmacovigilance regulations, Immunocore procedures, and inspection-readiness requirements. Support Health Authority questions, audits, inspections, deviation investigations, and CAPA activities. Serve as a best-practice resource and lead process improvements, including development or revision of SOPs and work instructions. Maintain current knowledge of pharmacovigilance regulations, industry guidance, and relevant therapeutic-area science. SUPERVISORY RESPONSIBILITY This position does not have direct line management responsibilities. COMPETENCIES Strong understanding of pharmacovigilance principles, benefit-risk assessment, and global drug safety regulations. Scientific and analytical thinking with the ability to interpret complex safety data. Experience performing signal detection and aggregate safety analyses. Excellent written communication and scientific writing skills. Strong organizational and project management abilities. Ability to work independently while collaborating effectively across multidisciplinary teams. Sound judgment, attention to detail, and commitment to patient safety and regulatory compliance. Proficiency with safety databases and pharmacovigilance systems. EXPERIENCE