Regulatory Safety Writer CLIN BIOSCIENCES
CLIN BIOSCIENCES
Office Location
Full Time
Experience: 2 - 2 years required
Pay: INR 500000 - INR 800000 /year
Type: Full Time
Location: Bangalore
Skills: drug safety, Pharmacovigilance, healthcareprojectmanager, medicalreview, regulatorysafetywriter, riskmanagementplans
About CLIN BIOSCIENCES
Job Description
Roles and Responsibilities
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Prepare and review high-quality aggregate safety reports for regulatory submissions.
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Author and update Risk Management Plans, Core Safety Information, Company Core Data Sheets, and Safety Narratives.
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Collaborate with global cross-functional teams including pharmacovigilance, medical affairs, regulatory, clinical, and biostatistics.
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Interpret and summarize safety data from various sources including clinical trials, real-world evidence, and post-marketing surveillance.
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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