job details for:
Medical Affairs – Drug Safety Physician/Doctor Jobs - London

Medical Affairs – Drug Safety Physician/Doctor Jobs - London (Job Ref: WR/JOBS/24661-11085)

Job Description :

Flame Pharma Medical Affairs – Drug Safety Physician/Doctor Job - London:

Job Summary

Our client, a global clinical research organisation offering a wide range of comprehensive, clinical research services to the pharmaceutical, biotechnology and medical device industries, require an experienced Drug Safety Physician for their UK medical affairs operations.
An exceptional opportunity has arisen for an experienced Drug Safety Physician to contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.

Job Title

Drug Safety Physician/Doctor

Background

The medical affairs department of this global clinical research organisation require an experienced physician to be drug safety physician with responsibility for the provision of medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.

Key Responsibilities

• Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
• Ongoing safety surveillance and signal detection/analysis
• Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
• Provide medical input in all required safety reports, such as PSURs, Clinical Expert Statement, Investigator notification letters
• Review all documents assigned for scientifically relevant issues including drug safety
• Function as pharmacovigilance representative/medical or drug safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings
• Provide medical advice and support for the safety component of feasibility studies
• Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
• Support of Medical Directors as required
• Medical and scientific Pharmacovigilance review of literature reports including epidemiological background research, Clinical Trial Reports, Clinical Study Protocols and Clinical Trial (Serious) Adverse Event Reports
• Case files, narratives, coding, causality and expectedness assessment
• Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
• Writing of safety section, including benefit risk assessment, of PSURs,
• Clinical Expert Statements and other documents as required; general PSUR support
• Provide medical affairs guidance to Safety Staff during the case processing cycle
• Review and sign off technical documents with respect to medically relevant matters with particular attention to those relating to drug safety
• Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
• Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
• Participate in Proposal Development Teams (PDTs) for client bid meetings
• Maintain up-to-date knowledge of projects by attending Professional Society Meetings
• Provide medical safety expertise to client per request
Provide medical safety expertise and training to other personnel
• Be able to provide a 24 hours/day, 7 days/week availability per request
• Maintain a current medical license
• Keep current with professional and pharmacovigilance regulations and knowledge
• Accommodate Pharmacovigilance timelines through flexible approach to working hour

Qualifications and Experience

• Must be a fully registered physician (GMC registered)
• Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
• Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
• Computer skills
• Good knowledge of drug safety and the drug development process
• Comparable post-graduate experience in clinical research, pharmacovigilance or regulatory affairs
• Must have good English skills

Benefits

This represents a challenging career with a lot of responsibility and excellent opportunities for progression. An attractive remuneration package will be offered to successful candidates including a competitive salary

Key Words

Clinical Research Physician, Medical Director, Drug Safety, Pharmacovigilance, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This position is to be based in London.

For further information about this role, please contact Flame Pharma.