Medical Writer I / Medical Writer II
HyderabadFull-timeMid levelPosted 3 weeks ago
Mid-level pharma role at Parexel International India safety services in Hyderabad.
About the role
India - Hyderabad; India-Bengaluru; India-Mohali; India-Mohali-Remote; India-Hyderabad-Remote; India-Bengaluru-Remote; India-Mumbai-Remote When our values align, there's no limit to what we can achieve. Prepare, compile, and lead development of scheduled and ad-hoc aggregate safety reports including Periodic Safety Update Reports (PSURs)
What you'll do
- Prepare, compile, and lead development of scheduled and ad-hoc aggregate safety reports including Periodic Safety Update Reports (PSURs)
- Conduct independent signal detection activities by collecting and analyzing safety data from multiple sources including databases, clinical data, literature
- Prepare comprehensive signal assessment documents such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs)
- Conduct systematic literature searches and reviews to summarize safety data, identify emerging safety trends, and support signal evaluation and epidemiology assessments
- Manage signal tracking activities, maintain comprehensive signal logs, identify and resolve data discrepancies in safety data sources
What you need
- Pharmacovigilance