Associate Director - Safety Science
Posted 4 days ago by i-Pharm Consulting
Negotiable
Undetermined
Hybrid
London Area, United Kingdom
Summary: The Associate Director of Safety Science will play a crucial role in supporting the global pharmacovigilance team of a leading biopharmaceutical company focused on rare diseases. This contract position requires expertise in signal detection, case review, and aggregate report preparation, contributing to patient safety in a collaborative environment. The role involves medical review of safety reports, collaboration with various teams, and preparation of safety documents. The ideal candidate will have a strong background in pharmacovigilance and excellent communication skills.
Key Responsibilities:
- Perform medical review of pre- and post-marketing Individual Case Safety Reports (ICSRs), ensuring accurate MedDRA coding and appropriate assessments (seriousness, expectedness, causality).
- Support the follow-up of high-priority ICSRs to ensure complete and accurate safety data.
- Collaborate with Clinical Science, Medical Affairs, and Pharmacovigilance colleagues to identify and evaluate safety signals.
- Contribute to the creation and maintenance of safety surveillance and risk management plans.
- Prepare aggregate safety reports (e.g., 15-day Alert Reports, SUSARs, PSURs, US PADERs, DSURs, IND Annual Reports).
- Participate in Safety Management Team meetings and liaise with study teams, CROs, and regulatory partners.
- Support the preparation and review of clinical and regulatory safety documents, including protocols, CSRs, IBs, and submission materials.
- Interface with business partners in line with applicable Safety Data Exchange Agreements (SDEAs).
Key Skills:
- Degree in Nursing, Pharmacy, or Medicine (e.g., BSN, RN, PharmD, MD, DO or equivalent).
- Proven experience in pharmacovigilance/safety science within the pharmaceutical or biotechnology industry.
- Strong understanding of signal detection methodologies and global safety reporting requirements.
- Hands-on experience with Argus Safety Database and MedDRA coding.
- Excellent communication and collaboration skills across multidisciplinary global teams.
Salary (Rate): undetermined
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 experienced Associate Director of Safety Science to 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-marketing Individual Case Safety Reports (ICSRs) , ensuring accurate MedDRA coding and appropriate assessments (seriousness, expectedness, causality).
- Support the follow-up of high-priority ICSRs to ensure complete and accurate safety data.
- Collaborate with Clinical Science, Medical Affairs, and Pharmacovigilance colleagues to identify and evaluate safety signals .
- Contribute to the creation and maintenance of safety surveillance and risk management plans .
- Prepare aggregate safety reports (e.g., 15-day Alert Reports, SUSARs, PSURs, US PADERs, DSURs, IND Annual Reports).
- Participate in Safety Management Team meetings and liaise with study teams, CROs, and regulatory partners.
- Support the preparation and review of clinical and regulatory safety documents , including protocols, CSRs, IBs, and submission materials.
- Interface with business partners in line with applicable Safety Data Exchange Agreements (SDEAs) .
Key Deliverables:
- ICSR medical reviews using Argus safety database
- Signal evaluation documentation (quarterly assessments, work-ups)
- Completed aggregate reports and Risk Management Plans
- Presentation materials for internal safety committees and governance meetings
Qualifications & Experience:
- Degree in Nursing, Pharmacy, or Medicine (e.g., BSN, RN, PharmD, MD, DO or equivalent)
- Proven experience in pharmacovigilance/safety science within the pharmaceutical or biotechnology industry
- Strong understanding of signal detection methodologies and global safety reporting requirements
- Hands-on experience with Argus Safety Database and MedDRA coding
- Excellent communication and collaboration skills across multidisciplinary 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.