Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position? Proclinical is seeking an experienced Associate Director of 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 position requires strong analytical skills, attention to detail, and the ability to collaborate effectively with cross-functional teams.
Please note our client is looking for someone who is immediately available.
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.
- 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:
- Background in nursing, pharmacy, or medicine (e.g., BSN, RN, PharmD, MD, DO, or equivalent).
- Extensive years of working experience in hands-on signal detection & aggregate reporting.
- Previous history in rare diseases is highly desirable.
- Proficiency in safety databases, signal detection tools, and document-sharing/review software.
- Strong attention to detail, analytical skills, and excellent verbal and written communication abilities.
- Experience in pharmacovigilance or safety science, including ICSR review, signal evaluation, and report preparation.
- Ability to work collaboratively in a team-oriented environment.
- Our client is looking for someone who is available immediately, or someone that has a notice period that is less than 4 weeks.
If you are having difficulty in applying or if you have any questions, please contact Josh Bye at j.bye@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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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