Syneos Health Recruitment 2022.Syneos Health Notification full details below..Intrested and eligible candidates can Send Resume.Syneos Health is the only company in the biopharmaceutical services industry purpose-built to create greater success for our customers. At Syneos Health, clinical and commercial live under the same roof and constantly share real world knowledge and insights that lead to getting the job done better, smarter and faster.
- Department: Safety & Pharmacovigilance Specialist I
- Qualification: 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.
- Experienced:Must have 2+ Years of experience in ICSR Case Processing/Must have working experience in ICSR Data Entry
Job Description: Greeting from Syneos Health !!!!!
Important Details :
- Location: Gurgaon
- Post of date:07/10/2022
- Selection Process: The selection will be on the basis of Interview.
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
• 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.