Senior Safety Writer

3 weeks ago

Mumbai, Maharashtra, India Thepharmadaily Full time
Job Description

- Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, etc.
- Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical device reports.
- Draft Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
- 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 feedback.
- Author/review manuscripts, abstracts, and posters for conferences.
- Prepare medical information responses for Healthcare Professionals (HCPs).
- Perform/review signal detection activities and participate in signal/safety review meetings with clients.
- Act as a writing coach, devising training programs, and authoring/reviewing SOPs/WIs/process documents.
- Coordinate activities related to report writing across a team of writers if applicable.
- Assist in resource estimation and responding to RFPs as needed.
- Coordinate internal and external communication to gather required inputs.
- Resolve issues affecting project deliverables and ensure compliance with regulatory requirements.
- Promote a culture of high customer service and adherence to quality processes.

Qualifications:

- Bachelors degree in a relevant field.
- Excellent communication skills and attention to detail.
- Experience in writing safety reports and regulatory documents.
- Proficiency in SQL, Python, and Core Java preferred.
- Ability to mentor junior team members and conduct trainings.
- Strong analytical and problem-solving skills.
- Familiarity with regulatory requirements and guidelines.
- 1-8 years of relevant experience.

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