Associate Director Drug Safety

An innovative biopharmaceutical organisation is seeking an experienced Associate Director within Safety Surveillance and Aggregate Reporting to provide scientific and strategic leadership across global pharmacovigilance activities.

Key Responsibilities

• Lead safety surveillance activities for assigned products.
• Oversee signal detection and risk management activities.
• Author/review aggregate safety reports including DSURs, PBRERs, and PADERs.
• Lead development of EU and core Risk Management Plans (RMPs).
• Support safety sections for global regulatory submissions (NDA/MAA).
• Manage clinical and post-marketing safety activities.
• Ensure compliance with global pharmacovigilance regulations.
• Collaborate cross-functionally and mentor junior team members.

Requirements

• Degree in Life Sciences or related field; advanced degree preferred.
• Extensive pharmacovigilance experience within biotech/pharma.
• Strong expertise in signal management, aggregate reporting, and RMPs.
• Experience supporting global filings and regulatory interactions.
• Strong leadership, communication, and stakeholder management skills.

This role requires half the week to be spent on-site.

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