Senior Safety Writer

• 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.