Job Title
Safety & Pharmacovigilance Trainee (Contractual)
Company
Syneos Health®
Location: Gurugram, India
Job ID: 25101070
Updated: September 2, 2025
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by delivering innovative clinical, medical affairs, and commercial solutions. With over 29,000 employees in 110 countries, Syneos Health fosters a culture of diversity, inclusivity, and continuous development.
Position Summary
As a Safety & Pharmacovigilance Trainee, you will undergo training and mentorship to assist with key pharmacovigilance activities, including the preparation and processing of Individual Case Safety Reports (ICSRs), literature screening, drug coding, data management, and regulatory reporting. You will adhere to data privacy, Good Clinical Practices (GCP), regulatory guidelines, and project-specific procedures. Based on performance, trainees may transition into project roles post comprehensive training.
Key Responsibilities
Monitor and route incoming safety information to relevant projects.
Record and track ICSR documentation as per sponsor/customer specifications.
Redact patient-identifying information in line with data protection, ICH GCP, and GVP guidelines.
Assist in data entry and case creation in safety databases.
Perform file creation, tracking, retention, and maintenance (both electronic and paper).
Manage document translation processes as needed.
Support query follow-up and submission processes.
Assist in daily workflow reconciliation.
Participate in safety literature screening, drug coding, MedDRA coding, and maintenance of drug dictionaries.
Support narrative writing, coding of events, medical history, concomitant medications, and tests.
Aid in the preparation and submission of expedited safety reports in compliance with regulatory requirements.
Validate xEVMPD product records and perform manual recoding as needed.
Identify and manage duplicate ICSRs.
Conduct activities related to SPOR / IDMP.
Ensure submission of relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File.
Maintain knowledge of SOPs, Work Instructions, GCP, ICH guidelines, GVP modules, and drug development processes.
Foster professional relationships within project teams.
Participate in audits as required.
Apply regulatory intelligence in safety reporting activities.
Qualifications
Education & Eligibility
M.Pharm, Pharm.D, M.Sc + B.Pharm, BHMS, BDS, or Ph.D. (Pharmacy)
Passed out in 2025 (2024 passouts with strong interest in Pharmacovigilance may also apply)
Core Skills
Strong knowledge and interest in healthcare/scientific fields
Proficiency in Microsoft Office Suite and Outlook
Excellent organizational, documentation, multitasking skills
Strong written and verbal communication skills
Ability to work collaboratively in a team environment
High attention to detail and accuracy
Preferred Qualifications
Familiarity with safety databases, medical terminology, pharmacology, or pharmacovigilance
Experience with collaboration tools like Visio, Team Share, or equivalents
Employment Type
Contractual role for 1 year (extension subject to performance and business needs)
Additional Information
Tasks and responsibilities may vary based on company discretion.
The company complies with all applicable employment legislation and promotes diversity and inclusion.
Reasonable accommodations will be provided as required under the Americans with Disabilities Act.
Why Work With Syneos Health?
Strong career development and progression opportunities
Supportive and engaging management
Comprehensive training programs
Inclusive “Total Self” culture where employees can be authentic
Commitment to diversity and belonging
Application
Interested candidates can apply for the position or join the Syneos Health Talent Network for future opportunities.
Learn more: Syneos Health Website
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