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 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.

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