Pharmacovigilance Physician - Cambridge, UK
To provide medical input into the global Pharmacovigilance department and activities with the objective of ensuring medical integrity.
- Support the QPPV for medical safety matters
- Medical evaluation of individual case reports, including causality assessment and MedDRA coding
- Signal detection
- Medical advisory role
- Risk management activities
- Report writing and benefit risk analysis (pre- & post marketing)
- Preparing Risk Management Plans
- Responses to safety questions
- Aggregate report medical review
- Maintaining a strong GPVP & GCP knowledge.
- The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
Qualifications/ Experience required:
- Full understanding of drug development process.
- Medical degree with a sound clinical knowledge in diverse therapeutic areas: must be registered with the General Medical Council.
- Strong background in drug safety / pharmacovigilance
- Thorough knowledge of safety regulations and legal requirements
- Excellent communication skills including the ability to work with people at all levels.
- Excellent organisational and time management skills.
- Ability to be proactive, work on own initiative as well as part of a team.
- Computer literate and competent in the use of Pharmacovigilance databases
- Good attention to detail.
Attributes and Behaviours:
- Have the ability of prioritising, planning and organising workload.
- Maintain a positive working environment within the office
- Demonstrate a “can do” approach.
- Demonstrate highest level of confidentiality and discretion
- Willingness to travel if required.
- Extensive pharmaceutical experience in safety or clinical development
- Should either have or be prepared to take the Diploma in Pharmaceutical Medicine or equivalent qualification.
Location: Cambridge, UK
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