Description
Syneos Health is seeking a Safety & PV Specialist I to join their team in Hyderabad or Gurugram. The successful candidate will have 2.5-4 years of experience in pharmacovigilance and will be responsible for processing ICSRs, maintaining safety tracking, and performing literature screening.
Job 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 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 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
- 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 organisational skills with proven ability to prioritise and work on multiple tasks and projects.
- Detail-oriented with a high degree of accuracy and ability to meet deadlines.