Medical Safety Officer - PALM

Role: Medical Safety Officer (MSO) specializing in Post Approval Lifecycle Management within Johnson & Johnson's Product Safety division. Objectives include assessing and ensuring the safety of marketed and clinical-stage Innovative Medicine products, leading safety oversight, and risk management activities. Responsibilities encompass leading Safety Management Teams for assigned products, providing medical input to clinical and regulatory documents (e.g., RMP, CSR, PBRER), communicating safety findings to stakeholders, and collaborating across cross-functional teams to optimize safety data collection and assessment. The MSO advises on clinical trial design to mitigate risks, participates in regulatory interactions, and guides risk mitigation strategies.Qualifications include MD or equivalent with 2-5 years pharmacovigilance or relevant clinical experience; board certification or medical specialization preferred. Demonstrated knowledge of drug development, pharmacovigilance regulations, and clinical trial safety monitoring is essential. Skills required include leadership of global teams, strategic thinking, strong communication, and expertise in safety data evaluation. High-value biopharma specifics involve safety assessment of marketed and developmental pharmaceuticals, regulatory compliance, and global safety standards. The role reports to the Portfolio Safety Head and may involve stakeholder engagement at health authorities and external experts. Work setup is not specified but involves collaboration across multiple geographic locations.