Associate Director - Pharmacovigilance

Job Title:Associate Director, Safety Science

Location:London (Hybrid / Remote Flexibility)

Employment Type:Contract

Overview:

We are currently partnering with a leading global biopharmaceutical company that specializes in rare disease research and the development of life-changing therapies. With a strong pipeline and a focus on innovation, this organization is committed to advancing science and improving outcomes for patients with unmet medical needs.

Our client is seeking an experiencedAssociate Director of Safety Scienceto support their global pharmacovigilance team. This contract role offers an exciting opportunity for a safety professional with expertise in signal detection, case review, and aggregate report preparation to contribute to a collaborative and fast-paced environment focused on patient safety.

Key Responsibilities:

• Perform medical review of pre- and post-marketingIndividual Case Safety Reports (ICSRs), ensuring accurate MedDRA coding and appropriate assessments (seriousness, expectedness, causality).
• Support thefollow-up of high-priority ICSRsto ensure complete and accurate safety data.
• Collaborate with Clinical Science, Medical Affairs, and Pharmacovigilance colleagues toidentify and evaluate safety signals.
• Contribute to the creation and maintenance ofsafety surveillance and risk management plans.
• Prepareaggregate safety reports(e.g., 15-day Alert Reports, SUSARs, PSURs, US PADERs, DSURs, IND Annual Reports).
• Participate inSafety Management Team meetingsand liaise with study teams, CROs, and regulatory partners.
• Support the preparation and review ofclinical and regulatory safety documents, including protocols, CSRs, IBs, and submission materials.
• Interface with business partners in line with applicableSafety Data Exchange Agreements (SDEAs).

Key Deliverables:

• ICSR medical reviews usingArgus safety database
• Signal evaluation documentation(quarterly assessments, work-ups)
• Completedaggregate reports and Risk Management Plans
• Presentation materials forinternal safety committees and governance meetings

Qualifications & Experience:

• Degree inNursing, Pharmacy, or Medicine(e.g., BSN, RN, PharmD, MD, DO or equivalent)
• Proven experiencein pharmacovigilance/safety science within the pharmaceutical or biotechnology industry
• Strong understanding ofsignal detection methodologiesand global safety reporting requirements
• Hands-on experience withArgus Safety Databaseand MedDRA coding
• Excellent communication and collaboration skills acrossmultidisciplinary global teams

Interested in shaping the future of patient safety in rare diseases?

Apply now or contact us to learn more about this impactful opportunity.