Job Title: Safety & PV Trainee
Location: Gurugram, India (Hybrid)
Job ID: 25101125
Company: Syneos Health
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical development, medical affairs, and commercial insights. The company fosters a culture of innovation, inclusivity, and collaboration, aiming to simplify work processes and accelerate delivery of therapies globally.
Work Culture & Values:
Commitment to career development, technical training, and total rewards programs.
Inclusive Total Self culture promoting diversity, belonging, and authentic expression.
Strong focus on professional growth, collaboration, and quality outcomes.
Job Responsibilities
Enter, track, and maintain data in PVG quality and tracking systems for ICSRs.
Assist in processing ICSRs according to SOPs and project-specific safety plans.
Triaging ICSRs, evaluating data for completeness, accuracy, and regulatory reportability.
Code events, medical history, concomitant medications, and tests.
Compile complete narrative summaries and follow up on queries until resolved.
Assist in timely reporting of expedited reports per regulatory requirements.
Maintain safety tracking for assigned activities.
Conduct literature screening and drug coding; maintain MedDRA dictionaries.
Validate and submit xEVMPD product records; recode un-recoded product/substance terms.
Identify and manage duplicate ICSRs.
Perform activities related to SPOR/IDMP.
Conduct quality reviews of ICSRs.
Ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File as appropriate.
Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP, and regulatory requirements.
Foster 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
Educational background: Equivalent experience, skills, or education considered.
Knowledge of PV processes, regulatory requirements, and ICSR handling.
Familiarity with drug/biologic/device regulations, GCP, ICH, GVP standards.
Strong attention to detail, organizational skills, and ability to work under supervision.
Effective communication and team collaboration skills.
Willingness to learn and adapt in a fast-paced, evolving environment.
Additional Information
Tasks and responsibilities may evolve based on company discretion.
Syneos Health considers transferrable skills from previous roles.
The company complies with ADA and provides reasonable accommodations for essential functions.
Participation in the Talent Network is encouraged to stay connected with future opportunities.
Company Highlights
Worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the last 5 years.
Managed over 200 studies across 73,000 sites and 675,000+ trial patients globally.
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