Vice President, Global Pharmacovigilance

Key ResponsibilitiesThe 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 Immunocores 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 Committees 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.

EXPERIENCE & KNOWLEDGE

Essential

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.