Regulatory Safety Writer

Roles and Responsibilities

• Prepare and review high-quality aggregate safety reports for regulatory submissions.

• Author and update Risk Management Plans, Core Safety Information, Company Core Data Sheets, and Safety Narratives.

• Collaborate with global cross-functional teams including pharmacovigilance, medical affairs, regulatory, clinical, and biostatistics.

• Interpret and summarize safety data from various sources including clinical trials, real-world evidence, and post-marketing surveillance.

• Track timelines and ensure timely delivery of all safety documents.

Qualifications

• PharmD / M.Pharm / MBBS / BDS / MSc in Life Sciences or Pharmacology
• Certification in medical writing, regulatory affairs, or pharmacovigilance is an added advantage
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Interested to apply can share CV or call/WhatsApp to 9342735755