Syneos Health Released Job Openings On 02/09/2022. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
Vacancy Details:
Syneos Health Recruiting bachelor’s Degree in life science, registered nurse, pharmacist with 02+ years of Experience for Safety & Pharmacovigilance Specialist I Position.Complete Details for the Safety & Pharmacovigilance Specialist I as follows.
Important Details :
- Location : India
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application:02/09/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
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 report ability.
o Enters data into 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.
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