Patient Safety Associate I

MOHALI (IN)ONSITEPOSTED: 8/8/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
Parexel

ROLE DEFINITION & RESPONSIBILITIES

Process Individual Case Safety Reports (ICSRs) including data entry, MedDRA coding, narrative writing, and quality checks.
Conduct literature searches and reviews to identify potential adverse drug reactions and safety signals.
Support safety submissions to regulatory authorities and ethics committees within stipulated timelines.
Assist in signal detection, compliance tracking, and generation of safety metrics.
Coordinate follow-ups, query management, and reconciliation with internal teams.

REQUIRED VERIFIED SKILLS

Pharmacovigilance
MedDRA
ICSR Processing
Regulatory Compliance
ICH Guidelines

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Parexel is a leading global clinical research organization (CRO) that provides comprehensive biopharmaceutical services. They partner with pharmaceutical, biotechnology, and medical device companies to accelerate the development and market access of innovative therapies. Their services span the entire drug development lifecycle, from early-phase clinical research to regulatory consulting and commercialization.

TEAM SIZE: 20,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)

READY TO SUBMIT?

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