Company: Barrington James Clinical
Reference: cs med
Closing Date: 24 Dec 16
Type: Full Time
Salary (£): 100,000+
An opportunity to join a leading global pharmaceutical company and work within the corporate pharmacovigilance department. This business has a major global presence and this role would work at a global level on a strong pipeline of exciting products and excellent marketed products from which the revenue generated
What should you expect in the role?
The position will report to the Vice President of Drug Safety and Regulatory Affairs and primarily focus on developing safety surveillance programs that provide oversight for the conduct of all investigations of medical safety signals. The position would work across the whole clinical development process. - Oversight of the development of medical safety content for local risk management plans and risk mitigation strategies - Approval of final drafts of medical safety content of plans and strategies for allocated projects and geographical regions - Provide input in to the product development process and contribute to the design and analysis of clinical investigations for regional products - Lead in collaboration with quality assurance and compliance management teams in terms of potential impact on safety - Preparation of medical safety assessments for all products that are licensed or marketed within your Global remit - Provide medical safety input to local and regional management review boards, including information on observed trends of AEs - Review available medical safety information from multiple sources and making timely decisions including risk mitigation recommendations and developing risk management plans - Providing medical safety input to the in maintenance of labelling safety information - Advise on the appropriate medical safety strategy for regulatory authority submissions of safety data and provide input into development of safety elements of the submissions as required by the regional regulatory
· Completed medical degree preferably with a specialisation
· Clinical practice experience in chosen field
· At least 5 years experience in drug safety
· Preferable with leadership experience
· Able to display up-to-date knowledge of regulatory requirements for global pharmacovigilance
· Experience in RMP, DSUR, PSUR etc
· Able to critically evaluate safety data from sources such as clinical trials, literature, etc, and communicate and align stakeholders to safety decisions
· High ability to communicate internally and externally
· Ability to work as part of a team and display ideas constructively
The successful candidate will receive a very competitive basic annual salary, 25% bonus as well as benefits such as a company pension scheme, healthcare insurance, life assurance and more...
Want to find out more and APPLY NOW?
C.V. to email@example.com or call 0441293776644
C.V. to Chris Swain - Sales Manager EMEA
Keywords medic doctor physician pharmaceutical pharma pharmacovigilance drug safety PV medical director lead manager adverse events risk management AEs SAEs Germany corporate headquarters global position opportunity leadership drug safety
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