Safety & PV Specialist II (Literature Review)

Syneos Health

3 - 8 years

9 - 10 Lacs

gurugram

Posted:20 hours ago| Platform:

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Skills Required

medical affairs career development data management gcp clinical trials clinical development pharmacovigilance visio biomedical recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Understanding of regulatory requirements with respect to global and local literature.
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.
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 Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
o 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

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