Senior Drug Safety Evaluation & Risk Physician
A leading pharmaceutical client is searching for a Senior Drug Safety Evaluation & Risk Physician to join their team in the UK. The company specialises in various therapy areas including oncology, neurology, and gastroenterology, and employs several thousand across the globe.
- As assigned by the Global Safety Board Chair, acting as General Safety Officer (GSO) to proactively manage the global safety aspects for a specific product, or group of products as defined in company policies and SOPs.
- Acting as a member of the Global Safety Board - the body which manages pharmacovigilance globally for the company.
- As General Safety Officer (GSO) for an assigned group of products, supporting the collection, assessment, evaluation, distribution, and reporting of individual and cumulative safety reports.
- Leading the response to safety-related medical queries from regulatory authorities, external bodies, and internally for specified product.
- Leading safety evaluation for specified products, including signal detection and benefit-risk analysis.
- Providing safety expertise to the international project team for assigned products, including the production and maintenance of Risk Management Plans.
- Leading the production and amendment of safety information, including product labelling for specified products.
- Leading the safety related aspects of the design and running of clinical studies, including involvement in the protocol production, investigators brochure production, support to the study team, monitoring of safety signals, and involvement in the production of the clinical study report.
- Establishing and maintaining a high level of familiarity with the local, European, and international pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and acting as a point of reference for others.
- Contributing as a senior and respected member of the drug safety community in the day-to-day functioning of an effective regional and global drug safety network.
Skills and Requirements:
- The Senior Safety Evaluation Physician will be expected to hold a UK GMC-approved or similar medical registration.
- Demonstrable experience in post-registration clinical medicine.
- Experience with Product Safety Surveillance Systems, including the Electronic Safety Database and Signal Detection Software
- Previous experience in pharmacovigilance, during which a consistent record of strong contribution was demonstrated, in addition to success in tackling new challenges and responsibilities.
- 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 +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.