Full job descriptionRole: Associate Director of Pharmacovigilance
Location: Welwyn Garden City / Hybrid (2 days per week in the office)
Hours: Full-time
Pay: £67.96 - £75.51 per hour (PAYE) or £90 - £100 per hour (LTD/UMB )
Contract: 12-month contract, outside IR35


An excellent opportunity has arisen for an Associate Director of Pharmacovigilance to join one of our longstanding global pharmaceutical clients. This senior-level role will provide scientific leadership across pharmacovigilance and safety science activities, supporting both clinical development and post-marketing products whilst contributing to global product safety strategy.


Benefits:
*Hybrid working with 2 days per week in Welwyn Garden City
*12-month contract outside IR35
*25 days holiday + bank holidays
*On-site and free parking
*Opportunity to support global development and marketed products
*Exposure to strategic pharmacovigilance and safety science activities
*Senior-level role within a collaborative global team


The Requirements:
*Degree in Life Sciences or a related scientific discipline
*Postgraduate qualification (MSc, PhD, PharmD, Medical qualification or equivalent) advantageous
*Significant pharmacovigilance and safety science experience within the pharmaceutical industry
*Strong understanding of GxP, regulated processes and the end-to-end clinical trial lifecycle
*Experience leading post-marketing safety activities and benefit-risk assessments
*Experience producing aggregate safety reports, including DSURs and PBRERs
*Knowledge of signal detection, safety risk management and regulatory requirements
*Excellent communication, presentation and stakeholder management skills
*Ability to work independently and manage multiple priorities within a global environment


The Role:
*Provide pharmacovigilance and safety science support across development and marketed products
*Lead signal evaluation, signal detection and benefit-risk assessments
*Manage individual and aggregate case reporting activities, including DSURs and PBRERs
*Contribute to global product safety strategy across clinical development programmes
*Prepare and maintain CCDS, Investigator Brochures, Risk Management Plans and safety-related labelling documentation
*Provide safety oversight and input into study management activities
*Support safety risk management and regulatory submissions
*Present complex scientific data clearly to internal stakeholders and cross-functional teams
*Collaborate with global teams to support pharmacovigilance initiatives and strategic objectives
*Contribute to continuous improvements across pharmacovigilance processes and practices


If you’re keen to join an exceptional team who can offer strategic pharmacovigilance responsibilities, global exposure and the opportunity to influence product safety across the pharmaceutical lifecycle, then please apply to this Associate Director of Pharmacovigilance role below or call Chloe McCausland on between 8:30am - 5:00pm.