Medical Review Safety Physician,Associate Director

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Product Safety

Job Sub Function: Product Safety Risk Management MD

Job Category: Scientific/Technology

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

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.

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. 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