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 (RMPs), adhoc reports, and medical device reports.
• Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders.
• Conduct trainings for peers and junior team members and provide shadowing opportunities.
• Author/review manuscripts, abstracts, and posters for conferences.
• Perform/review signal detection activities and author signal reports.
• Act as a writing coach, devise training programs, and author/review SOPs/WIs/process documents.
• Coordinate activities related to report writing across a team of writers, if applicable.
• Assist in estimation of resource requirements and responding to Requests for Proposals (RFPs).
• Internal and external communication and coordination to obtain required inputs.
• Create and update labels, review literature searches, and perform routine surveillance.
• Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables.
• Ensure compliance with regulatory requirements and maintain a culture of high customer service.

Qualifications:

• Bachelor of Pharmacy degree
• 7 to 11 years of experience in pharmaceutical regulatory writing
• Expert proficiency in English language
• Strong problem-solving skills and ability to think creatively
• Commitment to diversity, inclusion, and equal opportunity employment