Safety & PV Specialist I – Literature Case Processing at Syneos Health, IND-Gurugram
Syneos Health is hiring for a Syneos pharmacovigilance job as a Safety & PV Specialist I for Literature Case Processing in IND-Gurugram. Candidates should have an M.Pharma / BDS / Pharm D Degree or Equivalent. Apply by following the link below.
Job Details
Job Requisition ID: 25111538
Remote Type: Office-based
Location: IND-Gurugram
Time Type: Full time
Posted On: Posted Today
Job Responsibilities
- 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.
- Maintains safety tracking for assigned activities as part of this pharmacovigilance role.
- 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.
Syneos Pharmacovigilance Job Eligibility Criteria
- Ideal candidate should have 2+ years of experience in Literature Data entry along with MLM experience.
- Should have M.Pharma / BDS / Pharm D Degree or Equivalent.
- Safety Database systems and knowledge of medical terminology required.
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
- Ability to work independently and in a team environment.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Further, nothing contained herein should be construed to create an employment contract. Applicants for this Syneos pharmacovigilance job should review the original notification before applying.