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Safety & Pv Coordinator (Hyderabad Office-Based)

Syneos Health
Syneos Health
Fresher years
3-5 LPA
Hyderabad, Pune, India
10 April 30, 2026
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety & Pharmacovigilance Coordinator – Hyderabad (Office-Based)

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