Overview
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 breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at jnj.com.
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 an individual. We respect the diversity and dignity of our employees and recognize their merit.
Responsibilities
- Provide medical expertise in the evaluation of safety data from a variety of sources as part of the Pharmacovigilance process and the operational aspects of individual case medical review.
- Physician-level medical review of safety information, determining medical and scientific relevance of adverse event reports within the product safety profile and other products in the same therapeutic area.
- Perform medical assessment of case-level and aggregate safety data for new safety concerns and trends; communicate issues to the MRSP Team Lead; support the Director, MRSP as needed.
- Participate in matrix management activities (e.g., Safety Management Team) and provide pharmacovigilance expertise on individual case reports.
- Contribute to cross-functional projects/teams; lead or participate in Safety Management Team activities, signal evaluation, and follow-up of critical cases and events of special interest (RMP-identified risks).
- Evaluate ICSRs for potential product quality issues (including device malfunctions, if applicable); perform extractive/aggregate review of line listings and PBRER/PADER activities; contribute to Investigator’s Brochure activities and watchlist updates.
- Support Operational activities such as CAPAs, SOPs, audits/inspections, and vendor oversight as assigned.
- Prepare slides for Proactive Safety Review and analyze applicable safety data in aggregate; assist in data interpretation and communication of findings.
- Coordinate with internal stakeholders (MSO, primary MRSP, MRP, SAS) on ADR determination and RSI updates; contribute to risk management planning and safety-related decision making.
- Maintain up-to-date knowledge on regulatory expectations and Good Clinical Practices; ensure effective communication with internal and external customers in a matrix environment.
Minimum Qualifications
- Physician (MD or equivalent) required; medical specialization is preferred.
- Minimum of 1 year of clinical practice after postgraduate training; minimum of 3 years of experience in industry, academia, or patient care settings required.
- Direct experience in pharmacovigilance preferred; limited PV experience considered on a case-by-case basis in the context of the overall application.
- Excellent verbal and written communication skills; ability to work in a team-oriented, matrix environment; fluent in written and spoken English.
- Working knowledge of Microsoft Office (Excel, Word).
- Ability to work independently with minimal supervision and meet tight deadlines.
Preferred/Additional Skills
- Clinical Operations, Compliance Management, Cross-Functional Collaboration, Developing Others, Risk Management, and Safety Investigations.
- Experience with Safety Surveillance, Serious Adverse Event reporting, SOPs, and Quality Control (QC).
- Technical credibility and ability to contribute to Safety-related decision making.
All content related to the role reflects internal descriptions and does not constitute a job offer. For the purposes of this description, all references to Johnson & Johnson apply to the employer. Do Not Sell or Share My Personal Information; Limit the Use of My Personal Information
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