Syneos Health Pune is Hiring Safety & PV Specialist II
- Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
- May assist in the preparation of the Safety Management Plan
- Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- 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.
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
- Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
- Participate in audits/inspections as required
- 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, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
What we’re looking for
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
- 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), TeamShare (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment
- Good 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
- Minimal travel may be required (up to 5%)