Job Title: Safety & Pharmacovigilance - Trainee (Contractual | 2025 Passout Only)
Location: Gurugram, India
Job ID: 25101070
Job Type: Contractual (1 year, subject to extension based on performance)
About the Company:
Syneos Health® is a leading integrated biopharmaceutical solutions organization that partners with clients to accelerate success. With 29,000 employees across 110 countries, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past five years. The company is dedicated to innovation, collaboration, and career growth, ensuring a workplace where “Work Here Matters Everywhere.”
Role Overview:
The Safety & Pharmacovigilance Trainee will assist in pharmacovigilance operations including ICSR processing, literature screening, MedDRA coding, data management, and preparation of safety reports. Comprehensive training will be provided before transitioning into project roles. This role offers an excellent opportunity for recent graduates to gain hands-on experience in pharmacovigilance within a global organization.
Key Responsibilities:
Monitor and route incoming safety information to appropriate projects.
Record and track ICSR documentation as per sponsor requirements.
Redact patient-identifying information per ICH-GCP, GVP, and data protection guidelines.
Assist in creating and entering cases into the safety database, following conventions.
Support file creation, tracking, and document maintenance.
Participate in query follow-up, submission processes, and workflow reconciliation.
Contribute to safety literature screening, drug dictionary maintenance, MedDRA coding, and narrative writing.
Assist in expedited and periodic safety reporting in line with regulatory requirements.
Validate xEVMPD product records, manage duplicate ICSRs, and support SPOR/IDMP activities.
Ensure compliance with SOPs, WIs, GVP, GCP, and regulatory requirements.
Support audits and maintain professional collaboration with internal and external teams.
Education & Eligibility:
M.Pharm, Pharm.D, M.Sc + B.Pharm, BHMS, BDS, or Ph.D. (Pharmacy).
Open to 2025 pass-outs (2024 pass-outs with strong interest in pharmacovigilance may apply).
Core Skills (Required):
Strong healthcare/scientific knowledge.
Proficiency in Microsoft Office Suite and Outlook.
Excellent organizational, documentation, and multitasking skills.
Strong written and verbal communication.
Ability to collaborate effectively in a team environment.
High attention to detail and accuracy.
Preferred Qualifications:
Familiarity with pharmacovigilance, safety databases, and medical terminology.
Exposure to collaboration tools such as Visio or Team Share.
Important Note:
This is a contractual role for 1 year, with extension based on performance and business needs. Trainees will undergo comprehensive pharmacovigilance training before handling project responsibilities.
Estimated Salary: ₹3.0 – 4.2 LPA (based on industry standards for PV trainee roles in Gurugram).
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