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SABR Associate II (UK)
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One of the top biotechnology companies in the world is looking to hire a SABR Associate II to join their team in the UK on a contract basis.
Role Overview:
PV Scientist serves as a product lead for Pharmacovigilance activities within the SABR Medical function. The Senior PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
Job Responsibilities:
- Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
- Leads signaling review process and product Safety Signaling Team meetings.
- Manages literature review for safety information.
- Collaborates with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
- Leads process for responding to safety questions from regulatory authorities.
- Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
- Leads and collaborates with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
Education, Skills and Experience:
- Bachelor's Degree in biologic or natural science; or health case discipline Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred D.
- Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Strong background in clinical trial drug safety is required
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Zico Dervish on +44 203 319 3051 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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