Syneos Health is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.
Post : Safety & PV Submission Spec II
Job description
• Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents
• Assists in study set-up for safety reporting only projects/programs
• Assists in the preparation of the Safety Reporting Plan for safety submissions only projects
• Maintains tracking of safety submissions
• Assists in the preparation of expedited and periodic safety report submission status updates, as required, for Sponsor/Customer
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
• Files documents according to project specific requirements (electronically or in hard copy as applicable).
• Forwards completed safety submission documents to clients and other relevant parties
• Fosters constructive and professional working relationships with all project team members, internal and external
• Assists in the preparation of data for internal project review meetings and participates as required
• Participates in audits as required/appropriate
• 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 an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process
Candidate Profile
• Should has 3-5 yrs of exp in Submissions experience in PV Case Processing
• Having experience in Clinical Trail Submissions is preferred
• Should have good experience in manual submissions
• Having experience for either of US/EU/APAC is considered
Additional Information
Experience : 3-5 years
Location : Gurugram
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Safety & PV
End Date : 20th June, 2022
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