Vice President (Pharmacovigilance and Drug Safety)
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Hobson Prior are looking for a Vice President (Pharmacovigilance and Drug Safety) for an exciting opportunity to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.
- Accountable for the creation and oversight of the Pharmacovigilance department, this will include hiring of staff, and ultimately consolidation of clinical safety databases from multiple CROs to a single vendor.
- Identify and escalate significant issues relating to compliance, budgets, timelines or other issues that jeopardize business objectives.
- To manage pharmacovigilance activities across all clinical studies, in co-operation with external vendors.
- Complete ongoing centralization and standardization of PV activities.
- Develop standardized methods and processes of surveying safety data from clinical trials. Develop core safety information initiative.
- Lead Safety Review Meetings for company products.
- Ensure compliance with GVP, GCP, GMP and all applicable regulations
- Ensure the establishment of monthly safety reporting compliance metrics of individual (e.g. ICSRs, SUSARs, etc.), aggregate, and periodic reports (e.g. DSUR) are 100% compliant both in terms of quality and timelines for in-house and contracted services.
- Develop and maintain SOPs as needed and ensure compliance
- Oversight of safety Vendors.
- All safety CAPAs for audit/ and/or inspection findings & deviations are closed by the due dates.
- Ensuring all critical and major GVP non-compliance issues are put through the CAPA process.
- Leadership experience including supervision and mentoring of pharmacovigilance staff.
Any other assigned duties.
- Have strong organisation, management, teamwork and interpersonal skills.
- To have excellent written and verbal communication skills.
- You will be excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- You will have previous experience in gene therapy.
- Requires a MD or minimum of 8 years' in the relevant role.
- Have knowledge of relevant FDA guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£40 - £45 per hour
Hobson Prior is currently recruiting for a Senior PV Quality Specialist to join a world-wide pharmaceutical organisation focused on the research and development of novel medicines
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