Proclinical is happy to advertise an opportunity for a Senior Pharmacovigilance Scientist position with a leading healthcare company that specialises in the fields of neurodegenerative diseases, haemophilia, and autoimmune disorders. This is a contract position at the company's Berkshire office.
The Senior Pharmacovigilance Scientist will serve as a product lead for Pharmacovigilance activities within SABR. They will be responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs/DSURS/Line Listings, RMPs), 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 will also serve 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. They will ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensuring the marketing authorisation remains in good standing.
Job Responsibilities:
- Leading the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned products, and evaluating safety data and signals as part of ongoing pharmacovigilance activities.
- Synthesising data from multiple sources and authoring signal evaluation reports.
- Leading signalling review process and product Safety Signalling Team Meetings.
- Managing literature review for safety information.
- Leading processes for responding to safety questions from regulatory authorities.
- Leading Aggregate Report management, including strategy, reviewing, and finalising aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation, and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
- Collaborating 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.
- Leading initiative for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management, and responding to ad hoc safety questions.
- Understanding, interpreting, analysing, and clearly presenting scientific and medical data in verbal and written format.
Skills and Requirements:
- A bachelor's degree in a biology or natural science field; health care disciplines will also be considered.
- An Advanced Degree (PhD, MPH, NP, PharmD, etc.) required.
- At least 7 years of Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- An understanding of medical concepts, terminology, and their applications.
- A strong foundation in Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
- A knowledge of case processing, expedited reporting rules, and safety database concepts.
- A basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
- Demonstrable leadership skills, along with an ability to work both as a member of a team and in an independent, self-directed manner.
- Strong problem solving, persuasion, and negotiation skills; being able to execute solutions/deliverables in a timely manner.
- Excellent written and oral English skills, with other European languages a bonus.
- A proven ability to focus and work with attention to detail, along with retaining critical information.
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 Kevin Hansberry on +44 207 440 0636 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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