PHARMAFull-time
Safety and PV Coordinator
DELHI NCR (IN)ONSITEPOSTED: 8/19/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities & Safety Case Coordination
Support end-to-end Individual Case Safety Report (ICSR) management, including intake, triage, tracking, and documentation of adverse event (AE) and serious adverse event (SAE) reports from clinical trials and post-marketing surveillance.
Assist in maintaining and reconciling pharmacovigilance safety databases, ensuring timely case processing in compliance with global regulatory timelines (FDA, EMA, CDSCO).
Perform document archiving, safety folder maintenance, and tracking of safety queries and regulatory submissions across global clinical studies.
Coordinate with cross-functional clinical operations, data management, and medical review teams to verify case data consistency and resolve discrepancies.
Quality, Compliance & Audit Readiness
Adhere strictly to Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), standard operating procedures (SOPs), and client-specific safety management plans (SMP).
Support internal quality audits and health authority inspection readiness activities by ensuring complete traceability and documentation of safety workflows.
Assist senior PV specialists and safety managers with periodic safety report compilation (PSUR/PBRER/DSUR) and safety data reconciliation.
Company Culture & Global Impact
Join a leading fully-integrated life sciences services organization that has contributed to 94% of all novel FDA-approved drugs and 95% of EMA-authorized products.
Work within an agile, collaborative clinical solutions environment driven by the mission to accelerate life-saving treatments to patients worldwide.
REQUIRED VERIFIED SKILLS
Pharmacovigilance (PV)
Adverse Event Reporting
ICSR Intake & Triage
Serious Adverse Events (SAE)
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
Safety Database Management
Regulatory Timelines
Clinical Research Documentation
COMPENSATION & REWARDS
₹3.5L - 6.0L per annum
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
RECOMMENDED TRAINING
1/5
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