Description
Syneos Health is seeking a Safety & PV Specialist II to join their team. The successful candidate will be responsible for performing various safety-related tasks, including entering information into PVG quality and tracking systems, triaging ICSRs, evaluating ICSR data, and maintaining safety tracking for assigned activities.
Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory report ability
- 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 the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
- Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA
- Manually recode un-recoded product and substance terms arising from ICSRs
- Identify and manage duplicate ICSRs
- Perform activities related to SPOR / IDMP
- Conduct quality review of ICSRs
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
- Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process
- Foster constructive and professional working relationships with all project team members, internal and external
- Participate in audits as required/appropriate
- Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
Qualifications:
- Education: B. Pharm / M. Pharm / BDS / BMS / MBBS
- Experience: 4-7 years in Safety & PV Specialist role
- Location: Gurugram-Hyderabad Office based