Safety Physician (CONTRACT)

Responsibilities

• Perform medical review of post-marketing ICSRs and spontaneous adverse event reports.
• Evaluate the medical context, completeness, and clinical relevance of reported events.
• Assess causality, seriousness, expectedness/listedness, and medical significance of safety cases.
• Apply medical judgment in accordance with company procedures and global pharmacovig vigilance regulations.
• Review and analyze literature safety cases and post-marketing safety data.
• Identify clinically meaningful findings or potential emerging safety concerns.
• Conduct signal detection, signal validation, and signal evaluation activities.
• Review safety data trends from multiple sources to support proactive safety surveillance.
• Identify emerging safety trends and potential risks associated with Papzimeos.
• Escalate significant findings through appropriate safety governance processes.
• Support benefit-risk assessment activities for Papzimeos.
• Contribute medical input to ongoing evaluation of the product safety profile.
• Review and provide medical input into PADERs, PSUR/PBRERs, and signal reports.
• Ensure safety conclusions are medically accurate and scientifically justified.
• Participate in signal management meetings and safety governance discussions.
• Present medical assessment of safety signals and support cross-functional decision-making.
• Provide medical assessment for special situation cases including pregnancy, medication errors, and product quality complaints associated with adverse events.
• Determine potential safety implications and reporting requirements when applicable.
• Author and medically review Health Hazard Assessments (HHAs) in response to Product Quality Complaints (PQCs).
• Ensure accurate evaluation of potential patient risk, clinical impact, and regulatory reporting requirements in alignment with applicable safety and pharmacovigilance standards.
• Support safety labeling updates based on emerging safety data.
• Provide medical rationale for proposed safety language changes in product labeling documents.
• Provide medical input for Medical Information Call Center custom response preparation and review.
• Ensure responses are medically accurate, consistent with approved labeling, and aligned with medical information requirements.
• Collaborate with pharmacovigilance, regulatory affairs, medical affairs, and quality teams.
• Support alignment of safety activities across cross-functional stakeholders.
• Ensure compliance with global pharmacovigilance regulations, ICH guidelines, and internal SOPs.
• Maintain high-quality and inspection-ready safety review practices.
• Support responses to regulatory authority safety queries related to marketed products.
• Provide medically sound and scientifically supported input for health authority communications.

Qualifications

• MD/MBBS required.
• Experience in post-marketing pharmacovigilance/drug safety.
• Strong knowledge of FDA and EMA PV regulations, ICH E2 guidelines, signal detection methodologies, benefit-risk assessment, MedDRA.
• Experience with safety databases and signal detection tools preferred.

Skills

• Strong medical judgment.
• Analytical thinking.
• Signal interpretation.
• Scientific writing.
• Attention to detail.
• Cross-functional collaboration.

Benefits

• Ability to work up to 30 hours per week depending on need.

Pay

• N/A

Schedule

• N/A

Company

• Preference: Oncology/rare disease/gene therapy experience.

Equal Opportunity Employer

• MFDV