Associate Director, Safety Science
This Associate Director position will be required to support safety surveillance and risk management activities for biopharmaceutical products. In this role, you will perform medical reviews, evaluate safety signals, and contribute to the preparation of safety reports and regulatory submissions.
This is a fully remote position based in the UK, office in London.
Please note our client is looking for someone who has no more than 1 months notice or immediately available.
Key Responsibilities:
* Conduct medical reviews of individual case safety reports (ICSRs) and aggregate safety data to ensure accuracy in coding, seriousness assessments, causality, and regulatory reporting.
* Collaborate with internal teams to identify, evaluate, and manage safety signals.
* Responsible for providing labelling input, HA responses and risk management strategy.
* Assist in follow-up activities for important ICSRs to gather relevant information.
* Develop and contribute to safety surveillance and risk management plans for drug development programs.
* Prepare and review expedited and aggregate safety reports, including 15-day Alert Reports, SUSARs, PSURs, PBRERs, US PADERS, and DSURs.
* Participate in Safety Management Team meetings and liaise with clinical study teams, regulatory affairs, and external partners as needed.
* Support the preparation and revision of product labelling, Risk Management Plans (RMPs), and other safety-related documents.
* Assist in drafting safety sections of investigator brochures, protocols, informed consent forms, and regulatory submissions.
* Represent Global Patient Safety in cross-functional meetings and external engagements.
Key Skills and Requirements:
* Degree/MSc/PharmD/MD or PhD
* 5+ years hands-on signal detection & aggregate reporting experience.
* Experience in Global Safety Strategy & Supporting Safety Committee Meetings.
* Global/EU/US regulatory engagement experience.
* Previous history in rare diseases is highly desirable.
* Proficiency in safety databases, signal detection tools, and document-sharing/review software.
* Ability to work collaboratively in a team-oriented environment.
* Immediately or 1 month notice
If you are having difficulty in applying or if you have any questions, please contact Josh Bye at j.bye@proclinical.com.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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