Roles & Responsibilities:
• Lead authoring and review of aggregate safety reports (PSUR/PBRER, DSUR, PADER, Annual Reports).
• Prepare benefit–risk evaluations, signal detection reports, and ad hoc regulatory safety documents.
• Author and review RMPs, safety update reports, addendum reports, and CTD summaries (Clinical & Non-Clinical Overviews, Clinical Summaries).
• Develop and update product labeling documents (CDS, USPI, SmPC/SPC, Medication Guides).
• Conduct scientific literature reviews, recommend label updates, and prepare justification documents.
• Generate and review line listings, summary tabulations, CFIs, and CFCs.
• Prepare medical information responses for healthcare professionals (HCPs).
• Coordinate safety writing projects including resource planning, timelines, and cross-functional communication.
• Act as primary client contact for safety writing deliverables and ensure quality, compliance, and audit readiness.
• Support RFPs, resource estimation, metrics tracking, and mentor junior writers.
Qualification:
• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (Master’s/PhD preferred).
Experience:
• 5–7 years of experience in the pharmaceutical industry or minimum 4 years in medical/safety writing.
Skills:
• Strong expertise in pharmacovigilance regulations, ICH guidelines, and aggregate safety reporting.
• Excellent scientific writing and communication skills.
• Proficiency in MS Office and strong project coordination abilities.
• Client-facing, leadership, and mentoring skills.
• In-depth understanding of disease areas, drug safety lifecycle, and risk management.
About the Organization:
Fortrea is a global clinical development and pharmacovigilance services company supporting pharmaceutical and biotech organizations worldwide. With a strong focus on scientific excellence, regulatory compliance, and patient safety, Fortrea offers professionals the opportunity to lead complex global safety projects in a collaborative and growth-driven environment.
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