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Regulatory Safety Writer CLIN BIOSCIENCES

2.0 - 5.0 years

0 - 0 Lacs

bangalore, chennai, united arab emirates

On-site

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 affa...

Posted 4 months ago

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