Senior Manager, Pharmacovigilance Scientist

Immunocore; Oxford; On-site; GBP 90,000 - 150,000; Full time

Job summary

Immunocore in the United Kingdom seeks a Senior Manager, Pharmacovigilance Scientist to lead product-level safety surveillance and risk management across the lifecycle. You will collaborate with Safety Physicians and PV Operations to drive safety strategy on cross-functional projects.

The role requires extensive experience in global PV regulations, signal detection, and expert medical writing. Strong leadership and a track record of guiding teams and vendors are essential.

Qualifications

• 12+ years of experience in biotechnology or pharmaceutical industry.
• Experience supporting safety surveillance for clinical development and/or marketed products.
• Experience with signal detection, evaluation, and benefit-risk assessment.
• Experience authoring or contributing to DSURs, PBRERs/PSURs, PADERs, RMP.
• Working knowledge of global pharmacovigilance regulations (FDA, EMA, MHRA, ICH, GVP, CIOMS).

Responsibilities

• Lead safety surveillance for assigned investigational and/or marketed products.
• Lead signal detection, evaluation, documentation, communication, and closure per Immunocore procedures and global requirements.
• Integrate safety data from trials, ICSRs, literature, and analyses.
• Lead benefit-risk assessments and communicate recommendations to Safety Management Teams.
• Escalate emerging safety issues to senior stakeholders.
• Oversee DSURs, PBRERs/PSURs, PADERs and other reports.
• Lead or review Investigator Brochures, Safety Information, and risk plans.
• Ensure safety documentation is rigorous, consistent, and compliant.
• Manage timelines and cross-functional review processes.
• Develop product-specific pharmacovigilance and risk management plans.
• Provide PV input to development and lifecycle management.
• Collaborate with Regulatory and Medical Affairs on safety messaging.
• Represent PV on program teams and governance forums.
• Coordinate external vendors and cross-functional contributors.
• Maintain inspection readiness and respond to queries and CAPA.

Skills

Pharmacovigilance

Signal detection

DSURs

PBRERs/PSURs

Regulatory compliance

Safety data analysis

Leadership

Cross-functional collaboration

Medical writing

Vendor management

Education

Bachelor's degree in life sciences or related

Advanced degree (MS/PhD/PharmD) preferred

PV certification desirable

Tools

Argus

ARISg

Veeva Safety

Job description

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 & KNOWLEDGE

• 12+ years of experience within the biotechnology or pharmaceutical industry.
• Experience supporting safety surveillance for clinical development and/or marketed products.
• Experience with signal detection, signal evaluation, and benefit-risk assessment.
• Experience authoring or contributing to aggregate safety reports (DSURs, PBRERs/PSURs, PADERs, RMP).
• Working knowledge of global pharmacovigilance regulations including FDA, EMA, MHRA, ICH, GVP, and CIOMS.
• Proven track record of presenting complex scientific and safety information to governance bodies and senior/executive-level colleagues.
• Experience participating in or supporting regulatory inspections, audits, and CAPA remediation.
• Demonstrated capacity to lead cross-functional project teams and mentor junior professional colleagues.
• Experience with biologics, oncology, immunology, TCR therapeutics, or other advanced therapies.
• Experience with post-marketing safety commitments, PASS studies, or risk-minimization effectiveness assessments.
• Experience working with safety databases such as Argus, ARISg, or Veeva Safety.
• Working familiarity with pharmacoepidemiology, observational studies, or real-world data.
• Relevant professional certification in pharmacovigilance or drug safety.

Education & Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or a related scientific discipline.
• Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific discipline (MS, PharmD, PhD preferred).
• Relevant pharmacovigilance or drug safety certification is desirable.
• Excellent written and verbal English communication skills.