Proclinical is partnering with a leading human resources company to advertise a vacancy for a Senior Drug Safety Manager (Surveillance & Risk) position. The organisation invests in new technologies and is dedicated to connecting clients and candidates whilst offering a seamless digital experience. Based in Maidenhead, this position offers an exciting opportunity to work with a dynamic and innovative company that combines its passion for people and the power of today's technology to create an experience that is inherently more human. This position will last for a 6-month period, with a high likelihood of extending.
The Senior Drug Safety Manager will serve as a product lead for Pharmacovigilance activities within the SABR Medical function and will served 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 oversee and lead the process for safety signal management activities, aggregate report respond to safety questions from internal and external stakeholders, review medical and scientific literature for safety information, and support Clinical Trial PV medical activities.
Job Responsibilities:
- Building strong internal network of brand managers, clinical staff, and others in such functions as Business Analytics, Strategy, Business Development, Regulatory, and Legal.
- Leading the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluating safety data and signals as part of ongoing pharmacovigilance activities, including synthesising data from multiple sources and authoring signal evaluation reports.
- Leading signalling review process and product Safety Signalling Team meetings. Manages literature review for safety information.
- 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.
- Responding to safety questions from regulatory authorities and leading the process to do so.
- Contributing to and leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, and signal management, and responding to ad hoc safety questions.
- Leading and collaborating with Aggregate Reports on strategy, reviewing and finalising aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation, Mitigation Strategy Plans, and Risk Management Plans.
Skills and Requirements:
- An undergraduate degree in a relevant discipline.
- Demonstrable experience in Pharmacovigilance, with experience in a similar role beneficial.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Kevin Hansberry at +44 07 440 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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