Medical Review Safety Physician, Associate Director

The Associate Director MRSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the MRSP Team lead. The Associate Director, MRSP may provide support to a Director, MRSP as required. Additionally, the Assoc. Dir., MRSP may participate in matrix management activities (e.g., Safety Management Team) and provide pharmacovigilance expertise on individual case reports.

Active participation in MRSP activities which may include, but are not limited to:

• Medical review:
  • May perform medical review of Individual Case Safety Reports (ICSRs) from all case types
• Provide support for the Director, MRSP as needed
• Liaise with MSO, primary MRSP, Molecule Responsible Physician (MRP), Safety Analysis Scientist (SAS) on operational aspects of Adverse Drug Reaction (ADR) determination and RSI table annual updates
• Prepare slides for Proactive Safety Review and analyze the applicable data in aggregate
• May analyze and assess Critical Cases (DME, EVOI, etc.)
• Detect single case signals/through validation
• Member of Safety Management Team
• May participate in Signal Evaluation
• Ensure Follow-up of all critical case/ Events of Special Interest (Risk Management Plan (RMP) identified risks)
• Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable).
• Perform aggregate review of cases in line listings
• PBRER/PADER activities
• Investigator Brochure activities
• Watchlist activities
• Targeted Follow-up Questionnaires creation/update
• Vendor oversight activities as assigned
• Additional ad hoc activities that may require physician input, example:
  • Standard Operating Procedures (SOPs)
  • CAPAs
  • Audits/inspection activities
  • Lead cross functional projects/teams as assigned.

Minimum Qualification

• A Physician (MD or equivalent) is required.
• Medical specialization is preferred.
• A minimum of 1 year in clinical practice after postgraduate training program is preferred.
• A minimum of 3 years of experience in industry, academia or patient care settings is required.
• Direct experience in pharmacovigilance is preferred. Limited PV experience will be considered on a case-by-case basis in the context of the applicant’s overall application.
• Experience and knowledge of Good Clinical Practices is required.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers in a team-oriented, matrix environment is required.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products, including Excel and Word.
• Must be able to work independently with minimum supervision to meet tight deadlines.

Other Requirements

Not applicable

Required Skills:

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Cross-Functional Collaboration, Developing Others, Medicines and Device Development and Regulation, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Surveillance, Tactical Planning, Team Management, Technical Credibility