Syneos Health Life Sciences Safety & PV Specialist Opening, Apply Online
Syneos Health Life Sciences Safety & PV Specialist Opening, Apply Online. Syneos Health Safety & Pharmacovigilance Specialist I vacancy available. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Safety & Pharmacovigilance Specialist I
Location – Asia Pacific – IND-Pune-Yerwada-Jail-Rd, India, India
Job ID – 22004133
Description
Job responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
o Enters data into the safety database.
o Codes events, medical history, concomitant medications and tests.
o Compiles complete narrative summaries.
o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. - 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.
Qualifications
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.
- Should have 2+ years of relevant PV case processing experience
Should have 1+ years of case processing experience in Clinical Trial
Should have worked on Argus database - 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 the 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
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