Description
Syneos Health is seeking a Safety & PV Specialist (SS I) to work in their Gurugram office on a night shift.
The role involves entering information into PVG quality and tracking systems, processing ICSRs, triaging and evaluating ICSR data, and maintaining safety tracking for assigned activities.
Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR
- Assist in processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability
- Enter data into safety database
- Code events, medical history, concomitant medications, and tests
- Compile complete narrative summaries
- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved
- Assist in generating timely, consistent, and accurate reporting of expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, and MedDRA coding
- Validate and submit xEVMPD product records
- Manage duplicate ICSRs and participate in audits as required
Qualifications:
- Education: B. Pharm / M. Pharm / BDS / BMS / MBBS
- Experience: Minimum 2.6-4 years of PV experience
- Skill for Sr Safety & PV Specialist: ICSR case processing experience along with Quality Check (QC) Experience is mandatory
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture