Medical Review Safety Physician - Manager

About the role

The Medical Review Safety Physician (MRSP) will provide medical expertise in evaluating safety data across multiple sources as part of Johnson & Johnson's pharmacovigilance program. Based in Taguig, Manila, the role focuses on assessing adverse event reports, identifying safety signals, and supporting risk management for selected products.

Key responsibilities

• Determine medical and scientific relevance of spontaneous, clinical, non‑clinical, and literature adverse event reports.
• Participate in Safety Management Team activities and provide pharmacovigilance expertise on individual case reports.
• Analyze and assess SUSARs, critical cases, and single‑case signals.
• Prepare aggregate safety reports such as PBRERs, ad‑hoc regulatory submissions, and Risk Management Plans.
• Review Designated Medical Events, Events of Interest, and other safety data sources.
• Maintain watchlists, investigator brochures, and support signal detection and trend analysis.

Required profile

• Medical degree (MD) with substantial experience in pharmacovigilance or drug safety.
• Strong clinical knowledge of therapeutic areas relevant to the assigned products.
• Proven ability to assess safety data and communicate findings to cross‑functional teams.
• Familiarity with regulatory requirements and safety reporting standards.

Required skills

• Pharmacovigilance and adverse event assessment.
• Signal detection and safety signal evaluation.
• Preparation of PBRERs, Risk Management Plans, and other regulatory safety documents.
• Understanding of SUSAR classification and critical case management.