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Senior Safety Writer
ConfidentialMumbai8 days ago
Job descriptionWrite and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports. Author and review Risk Management Plans, adhoc reports, and medical device reports. Prepare Common Technical Document Summaries including Non-Clinical and Clinical Overviews. Conduct trainings for peers and junior team members, providing shadowing opportunities and hands-on experience. Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders in managing and tracking such feedback. Author or review manuscripts, abstracts, and posters for conferences. Prepare medical information responses for Healthcare Professionals (HCPs). Perform and review signal detection activities and participate in signal review meetings with clients. Act as a writing coach and devise training programs. Author or review Standard Operating Procedures (SOPs), Work Instructions (WIs), and process documents. Coordinate report writing activities across a team of writers if applicable. Assist in resource estimation and responding to Requests for Proposals (RFPs). Communicate internally and externally to obtain required inputs. Create and update labels and review label changes, authoring proposed label text. Conduct literature searches and reviews for various reports and routine surveillance. Perform additional activities as per project requirements or manager s discretion. Ensure compliance with regulatory requirements and maintain a culture of high customer service.
Qualifications :
- bachelors degree in a relevant field.
- Previous experience in safety writing or related roles.
- Strong communication and organizational skills.
- Ability to work effectively in a collaborative team environment.
- Attention to detail and ability to manage multiple tasks simultaneously.
Skills Required
Technical Writing, Regulatory Compliance, Risk Assessment, Data Analysis
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Senior Safety Writer • Mumbai
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