Job Description: Summary
Opportunity for a physician with experience in pharmacovigilance to join a team of physicians and scientists at the UK affiliate of a global pharmaceutical company. The role has full accountability for aspects of safety related to development and marketed products, including single case assessment, aggregate reporting, signal detection and risk management throughout the product life-cycle. This is a high impact position that contributes to the safety of patients worldwide and to the success of the company’s products.
Company
This blue-chip pharma company is a leading-edge R & D organization and one of the foremost suppliers of pharmaceutical medicines in the Oncology, Transplantation, Rheumatology, Immunology and Neurology therapeutic areas. The global development team based in the UK also leads major studies in Internal Medicine. With a strong focus on employee development, the company is committed to providing an environment in which employees can develop the right skills to achieve their career aspirations.
Location
South, Central
Role
(DSP) Operations Physician, Drug Safety
Key aspects of the role
• Ensuring all safety processes are properly supported (pharmacovigilance, signal detection, risk management, benefit/risk)
• Responsibility for the safety management of a portfolio of mature products
• Contributing to the development of the clinical development plan throughout the exploratory and confirmatory phase to optimize the benefit/risk ratio and to clinical study protocols from a safety perspective
• Supporting the clinical and life cycle teams in bringing the safety expertise in interaction with Health Authorities, Data Safety Monitoring Boards and Investigators
• Acquiring and contributing knowledge of relevant drug class and/or competitor safety issues
• Contributing to clinical study reports, annual safety reports, project plans, project documents and presentations
• Contributing to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve submissions from a safety perspective
• Reviewing all communication to the public from a safety point of view
• Planning and performing an evaluation of safety data to detect safety signals and on an ongoing basis, evaluating benefit/risk ratio and how to manage patients within and across trials
Experience
Candidates must have had a sound background in General Medicine and experience of pharmacovigilance gained within the pharmaceutical industry or with a regulatory agency. Post graduate experience in a medical specialty will be advantageous.
Key requirements are
• Experience of drug development including the evaluation and interpretation of scientific and clinical data
ideally across a breadth of therapeutic areas particularly in relation to issue management, signal detection and evaluation
• Knowledge and understanding of pharmacovigilance regulatory requirements and general regulatory expectations
• Proven analytical thinking
• Ability to manage budgets and timelines
• Fluency in verbal and written English
• Strong written and verbal communication skills to a variety of levels and teams, internally and externally
• Persuasion, influencing and negotiation skills
• Ability to operate objectively and independently and as a member of a team
• Ability to interact effectively in a multifunctional and multicultural environment
• Computer literacy and familiarity with software and systems
Qualifications
All candidates must be medically qualified and fully GMC registered.
Benefits: Company Car/Allowance:
Bonus:
Pension:
Healthcare:
Life Insurance/Income Protection:
Holiday Entitlement:
Other: Relocation assistance (where appropriate), full support for PMST/HMT, professional fees paid etc
|
