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.