Senior Safety Writer

• 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.