Job Description
The Associate Director, Medical Review Safety Physician (Assoc. Dir., MRSP) has a primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.

Essential Job Duties and Responsibilities
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process as well as in the operational aspects of individual case medical review.

Key Responsibilities

• 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.
• 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

Johnson & Johnson is an equal opportunity employer. We respect diversity and dignity.