Location: Hyderabad, India
Secondary Location: Pune, India
Job Type: Full-Time
Company: Syneos Health
Job Requisition ID: 25105305
Experience Required: Minimum 1 Year Experience (Freshers Not Eligible)
About the Company
Syneos Health is a globally recognized biopharmaceutical solutions company focused on accelerating customer success through integrated clinical development, medical affairs, and commercial expertise. Operating across more than 110 countries with over 29,000 professionals worldwide, the organization is known for delivering innovative healthcare and pharmacovigilance solutions that support faster therapy development and improved patient outcomes.
Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance Coordinator for its Hyderabad office. This opportunity is ideal for pharmacovigilance professionals with prior experience in post-marketing surveillance (PMS), spontaneous case processing, and safety database management.
The selected candidate will be responsible for Individual Case Safety Report (ICSR) processing, pharmacovigilance compliance activities, safety data review, MedDRA coding, duplicate management, regulatory documentation, and support for global drug safety operations.
This role offers excellent exposure to global pharmacovigilance processes, regulatory standards, and safety reporting systems within an internationally recognized CRO environment.
Key Responsibilities
ICSR Processing & Case Management
Perform triage, assessment, and processing of Individual Case Safety Reports (ICSRs)
Review case data for completeness, accuracy, and regulatory reportability
Enter and maintain safety data within pharmacovigilance databases
Prepare detailed narrative summaries for adverse event cases
Identify missing information and conduct follow-up activities for query resolution
Safety Database & Coding Activities
Conduct MedDRA coding for adverse events, indications, and medical history
Perform drug coding and maintenance of drug dictionaries
Support manual recoding of unresolved product and substance terms
Manage duplicate ICSR identification and reconciliation activities
Regulatory & Compliance Support
Assist in expedited safety reporting as per global regulatory timelines
Support xEVMPD product record validation and submission activities
Participate in SPOR and IDMP-related pharmacovigilance activities
Ensure compliance with ICH-GCP, GVP guidelines, SOPs, and global safety regulations
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File documentation
Quality & Operational Support
Perform quality review of ICSRs and safety documentation
Participate in audits and inspection readiness activities
Collaborate with internal teams and external stakeholders for project coordination
Apply pharmacovigilance regulatory intelligence across assigned safety operations
Eligibility Criteria
Educational Qualification
B.Pharm or M.Pharm candidates only
Experience Required
Minimum 1 year of experience in:
Post-Marketing Surveillance (PMS)
Spontaneous Case Processing
Pharmacovigilance Operations
Freshers are not eligible for this role.
Preferred Skills & Technical Requirements
Hands-on experience with LSMV safety database preferred
Candidates with Argus Safety experience can also apply
Strong knowledge of:
Pharmacovigilance workflows
ICSR processing
MedDRA coding
Drug safety regulations
Clinical trial safety processes
Understanding of:
ICH-GCP
GVP Guidelines
Global pharmacovigilance regulations
Proficiency in Microsoft Office Suite including Excel, Word, Outlook, and PowerPoint
Excellent communication, analytical, and organizational skills
Ability to manage multiple safety projects under strict timelines
Why Join Syneos Health?
Work with one of the world’s leading CRO and pharmacovigilance organizations
Gain exposure to global safety reporting systems and regulatory frameworks
Opportunity to work on international drug safety and clinical development projects
Collaborative and growth-focused professional environment
Strong learning, training, and career advancement opportunities
About Syneos Health Global Impact
Over the past five years, Syneos Health has contributed to:
94% of Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ global clinical studies
73,000+ research sites
675,000+ clinical trial patients worldwide
Who Should Apply?
This role is best suited for:
Pharmacovigilance Associates
Drug Safety Professionals
PMS Case Processing Executives
Safety Database Specialists
M.Pharm and B.Pharm professionals seeking CRO pharmacovigilance opportunities in Hyderabad
Apply Now
Candidates interested in pharmacovigilance jobs in Hyderabad, drug safety careers in India, or global CRO opportunities can apply through the official company career portal.
For more verified global pharmacovigilance jobs, clinical research openings, and pharma career updates, visit ThePharmaDaily.com
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