Job description :
- Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports
- Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or significant safety issues
- Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables
- Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables
- Contribute to scientific publications and represent the company at scientific meetings and conferences
- Work with the project management team to implement quality and process improvement initiatives
- Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary of Responsibilities:




- Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned.
- Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
- Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level.
- Author/review RMPs, ad ho

📌 Principal Safety Writer (Mumbai)
🏢 Fortrea Development India Private
📍 Mumbai