Vice President, Global Pharmacovigilance

Location of role Gaithersburg, MD, US, Conshohocken, PA, US, Remote, US

Department Regulatory Affairs

Key Responsibilities The Vice President, Global Pharmacovigilance (GPV) will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical trials to post-marketing surveillance. They will work closely with cross-functional teams to develop and implement risk management strategies and will be responsible for ensuring compliance with all relevant regulations and guidelines. Build and direct the Pharmacovigilance team to provide strategic safety data analyses and independent input to support clinical development activities. Accountable for ensuring compliance for all pharmacovigilance regulatory reviews and submissions. Accountable for determining and evaluating all safety signals in conjunction with clinical team. Accountable for both pre-marketing and, where appropriate, post marketing GPV and risk management plans (RMP). Provides support to the clinical team with characterization of the safety profile of all assets in the pipeline. Develops and executes the outsourcing Pharmacovigilance plans in close coordination with the Clinical Organization to ensure consistency and reconciliation between SAE and AE databases. Establish and direct all medical safety advice and communications with the Immunocore senior leadership, investigators, key opinion leaders (KOL), and Health Authorities (HAs).

Provides high level scientific expertise in the safety evaluation and risk management of Immunocore products in clinical development and subsequent post-marketing setting

Key Responsibilities

• Develop and implement pharmacovigilance strategies and processes to ensure compliance with regulatory requirements.
• Manage the pharmacovigilance team and provide guidance and support to team members.
• Oversee the collection, analysis, and reporting of adverse events and safety data.
• Ensure timely submission of safety reports to regulatory authorities for individual events and aggregate reports.
• Collaborate with cross-functional teams to ensure the safety of products throughout their lifecycle.
• Provide pharmacovigilance and medical expertise to internal and external stakeholders.
• Stay up-to-date with the latest pharmacovigilance regulations and guidelines.
• Work with Contract Research Organizations (CROs) to ensure safety reporting, tracking, report generation and writing are consistent with Immunocore’s needs for compliance with internal and external SOPs and global HA requirements
• Works with appropriate individuals at Immunocore as well as PV and Clinical CROs to ensure reporting of expedited Individual Case Safety Reports (ICSRs) according to regulatory timelines
• Drives production and submission of periodic regulatory documents (DSURs, PSUR/PBRERs) according to agreed process and timelines
• Establishes Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects in development and leads review of data and management of safety issues
• For designated products, drives Pharmacovigilance and Risk Management Planning and leads production of Risk Management Plans
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters
• Safety representative on cross-functional clinical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important safety issues
• Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
• Leads or supports the safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
• Leads or supports the development of standard operating procedures (SOPs) and processes for Immunocore PV department.
• Ensure appropriate clinical safety risk communication and escalation within Immunocore to management and the Protocol Strategy Review Committee’s sub-team focused on safety review (PSRC)
• Analyse, prepare and write safety sections of Investigator Brochures (IBs) and annual updates to IBs.
• Provide the strategic leadership for the group;
• Plan and deploy skilled resources against project priorities;
• Contribute to development of budget and work within those allocated constraints throughout the fiscal cycle;
• Recruit, on-board, train, develop, perform, manage, and successful planning within GPV;
• Maintain an environment of continuous improvement within the team and contribute to continuous improvement in initiatives across GPV;
• Support and lead process improvement and implementation across Immunocore as it relates to safety;
• Work collaboratively with other functions to ensure consistency of approach across organization regarding safety;
  
  

SUPERVISORY RESPONSIBILITY

This position includes line manager responsibilities:

• Leads professionals both internally and externally with CROs to consider safety decisions.
• Support the strategic goals of GPV.
• Support the GPV team in strategic decision making.
• Promotes communication and cooperation among functions to create a spirit of unity in the organization.
  
  

COMPETENCIES

• Com munication Proficiency.
• Time Management.
• Collaboration Skills.
• Personal Effectiveness/Credibility.
• Flexibility.
• Technical Capacity.
• Stress Management/Composure.
• Appropriate experience with Regulatory Agency and KOL interactions;
• Proven history of effective leadership within a matrix organization;
• Excellent knowledge of pharmacovigilance relevant regulations and industry standards;
• Strong influencing skills with the ability to explain and defend a position in the face of opposition;
• Takes ownership of appropriate issues and appropriately delegates;
• Excellent analytical and problem-solving skills;
• Knowledge of relevant legislations and guidelines.
  
  

Essential

EXPERIENCE & KNOWLEDGE

• Strong knowledge of global pharmacovigilance regulations and guidelines
• Experience in PV, including from phase 1 through BLA/NDA and commercialization.
• Understanding of all components of PV, both strategic and operational
• Global experience in US/EU/ROW for commercial and development assets
• Experience in at least 1 BLA/NDA and global launch with RMM/REMs implementation
• Oversight experience of EU Qualified Person for Pharmacovigilance (QPPV)
• Knowledge of clinical development process
• Ability to work collaboratively in a cross-functional team environment.
• Experience in managing a team of professionals.
• Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality
• Expert evaluation skills and analytical thinking
• Excellent communication and interpersonal skills.
  
  

Education & Qualifications

MD or equivalent degree

Board certification in a relevant specialty

15-20 years of experience in pharmacovigilance and drug safety, with at least 5 years in a leadership role at Executive Director or higher.

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.