Safety & PV Specialist II - Literature Case Processing
GurugramFull-time4–7 yrsPosted 3 weeks ago
Mid-level operations role at Syneos Health in Gurugram. Needs 4+ years and a B.Pharm, M.Pharm or BDS.
About the role
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
What you'll do
- Enter information into PV quality and tracking systems for receipt and tracking of ICSRs
- Process literature-derived ICSRs according to SOPs and project-specific safety plans
- Evaluate case data for completeness, accuracy, and regulatory reportability
- Conduct data entry, coding, narrative writing, and follow-up activities as required
- Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events
What you need
- Excel
- Clinical research
- Data entry
- Pharmacovigilance
- MS Office
- PowerPoint
Good to have
- SOP writing
- Customer success