Job Title:
Safety & Pharmacovigilance (PV) Trainee
Location:
Gurugram, Haryana, India (Hybrid)
Company:
Syneos Health®
Job ID:
25101125
Job Category:
Pharmacovigilance / Drug Safety
Position Overview:
The Safety & PV Trainee will support pharmacovigilance activities, including processing Individual Case Safety Reports (ICSRs), literature screening, and maintaining drug safety databases. The role involves ensuring regulatory compliance, accurate coding, and high-quality safety reporting under guidance from the project team.
Primary Responsibilities:
Enter and track ICSR information in PVG quality and tracking systems.
Assist in processing ICSRs according to SOPs and project-specific safety plans.
Triage ICSRs, evaluate data for completeness, accuracy, and reportability.
Enter data into safety databases and code events, medical history, medications, and tests.
Compile narrative summaries for ICSRs.
Identify and resolve missing or inconsistent information through queries.
Assist in the timely and accurate reporting of expedited reports as per regulatory requirements.
Maintain safety tracking for assigned activities.
Conduct literature screening and review for safety and drug coding.
Perform MedDRA coding and manage drug dictionary updates.
Validate and submit xEVMPD product records, including coding of indications.
Recoding of un-coded product and substance terms from ICSRs.
Identify and manage duplicate ICSRs.
Perform activities related to SPOR / IDMP compliance.
Conduct quality reviews of ICSRs.
Ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as per SOPs.
Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP, and project plans.
Build professional working relationships with internal and external project team members.
Participate in audits as required.
Apply regulatory intelligence to all safety reporting activities.
Qualifications & Skills:
Education: Degree in Life Sciences, Pharmacy, Nursing, or related field (experience in biomedical literature and PV preferred).
Knowledge of pharmacovigilance processes, regulatory requirements, and safety reporting.
Familiarity with MedDRA coding and ICSR processing.
Strong analytical and documentation skills.
Ability to work independently and collaboratively in a hybrid environment.
Flexibility to handle additional tasks as assigned by management.
Work Environment & Additional Information:
Hybrid work model (office and remote).
Trainees will receive guidance, training, and mentorship.
Tasks and responsibilities may evolve based on business requirements.
The role supports career development and professional growth within pharmacovigilance.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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