Are you passionate about medical writing and drug safety reporting? Indegene, a global healthcare solutions provider, is hiring an Aggregate Report Medical Writer in Bengaluru, Karnataka. This is a full-time, on-site opportunity for professionals with experience in pharmacovigilance, aggregate safety reports, and regulatory medical writing.
This role offers career growth in a fast-paced environment at the intersection of healthcare and technology. If you have expertise in preparing PBRERs, DSURs, RMPs, and ad-hoc safety reports, this could be the perfect opportunity to advance your career.
Key Responsibilities
As an Aggregate Report Medical Writer at Indegene, you will:
- Author, review, and QC periodic aggregate reports (PBRERs, DSURs, SUSAR, PADERs/PAERs, RMPs, ACOs, ad-hoc reports).
- Ensure timely delivery, compliance with SOPs, and regulatory guidelines (ICH, FDA, GCP).
- Perform data validation, accuracy checks, and consistency reviews.
- Mentor junior writers, assist with review comments, and ensure high-quality document outputs.
- Collaborate with regulatory, clinical, and safety experts to meet client expectations.
- Review formatting and submission-ready documents per client-specific style guides.
- Support training, process improvements, and knowledge-sharing initiatives.
Qualifications
Must Have:
- Medical/M.Pharm/Pharm D/Life sciences degree.
- Minimum 2 years of experience in medical writing with end-to-end authoring of aggregate safety reports.
- Strong knowledge of regulatory documentation, global guidelines, and drug development process.
- Excellent written and verbal communication, organizational, and analytical skills.
Nice to Have:
- Mentoring or training experience.
- Strong interpersonal skills and adaptability in diverse work environments.
Why Join Indegene?
- Opportunity to work with a global healthcare leader.
- Exposure to cutting-edge regulatory and safety documentation projects.
- Career growth through mentorship, leadership pathways, and fast-track opportunities.
- Inclusive, diverse, and supportive workplace culture.
How to Apply
