Safety & PV Specialist (SS I / SS II / Sr SS)

Job Summary

Safety PV Specialist (SS I / SS II / Sr SS) - Night Shift

Job Responsibilities

• Must have 6+ yrs of experience in ICSR case processing and Quality Check / Quality Review.
• Applicants should be willing to work in night shift.
• The work location is Hyderabad / Gurugram, candidate should be willing to work at Hyderabad / Gurugram office.
• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arises from ICSRs.
• Identification and management of duplicate ICSRs.
• Activities related to SPOR / IDMP.
• Quality review of ICSRs.
• Ensures 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.
• Maintains 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.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Participates in audits as required/appropriate.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Qualifications

• Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)
• Location: Gurugram-Hyderabad/Pune Office based
• Skill for Sr Safety PV Specialist: ICSR case processing experience along with Quality Check (QC) Experience is mandatory
• Experience - Sr Safety PV Specialist: Minimum 6 years of PV experience
• Safety PV Specialist I - Minimum 2.6 years of PV experience
• Safety PV Specialist II - Minimum 4 years of PV experience
• Immediate/Early joiners will be preferred
• Applicants should be fine to work from night shift

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.