[ref. x99249402] Senior Drug Safety Physician

Senior Drug Safety Physician needs 7-10 Years of Experience Required

Senior Drug Safety Physician requires:

• Thorough knowledge of the pharma industry especially clinical research and global regulatory requirements and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk managements strategies.
• Thorough knowledge of FDA and ICH safety reporting regulations and guidelines.
• Demonstrated strategic and critical thinking, strong communication skills (both oral and written).
• CNS, Respiratory, Neurology therapeutic area experience highly desired, but not required.
• Ability to work effectively in teams, strong interpersonal skills and the ability to lead directly or indirectly with influence.
• Strong problem solving, conflict resolution and analytical skills.
• 7-10 Years of Experience Required
• drug safety
• FDA
• ICH
• medical review
• mitigation
• neurology
• problem solving
• safety management
• SMP
• strong communication skills
• therapeutic
• clinical trials
• product lifecycle
• regulatory safety
• clinical research
• clinical study
• CNS
• Coding
• CSR

Senior Drug Safety Physician duties:

• The PVRM Physician will be responsible for; the PVRM medical aspects of clinical trials including review/addressing safety queries related to Protocol Informed Consent Form (ICF) Safety Management Plan(SMP) Clinical Study report (CSR) IB safety section etc.
• Also, the medical review and assessment of individual case safety reports, including seriousness, expectedness, quality of the narratives, adverse event/concomitant medication coding and causality.
• The PVRM Physician will also provide medical safety subject matter expertise in the review and approval of documents including but not limited to:

Ø Aggregate safety reports including PSUR, DSUR, PADER.

Ø Company core data sheets, local approved labels.

• Regulatory safety inquiries.
• IRB / ethics committee safety questions.
• Health hazard assessments.
• The incumbent will also provide medical safety support for safety signal management throughout product lifecycle including signal detection, validation, development of risk mitigation strategies and authoring of signal evaluation reports.