Executive Director – Head of Global Pharmacovigilance

Our client is a pioneering, commercial-stage T cell receptor biotechnology company working to develop and commercialize a new generation of transformative medicines to address unmet needs in cancer, infectious and autoimmune diseases.

The Executive Director Pharmacovigilance Physician 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.

• 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 our client’s needs for compliance with internal and external SOPs and global HA requirements
• Works with appropriate individuals 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 our client’s PV department
• Ensure appropriate clinical safety risk communication and escalation within the company 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 initiatives across GPV;
• Support and lead process improvement and implementation across the company as it relates to safety;
• Work collaboratively with other functions to ensure consistency of approach across organization regarding safety

• At least 10 years of experience in pharmacovigilance and drug safety, with at least 5 years in a leadership role
• 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
• 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.