Job Title: Safety & Pharmacovigilance Specialist I – Medical Device & Product Quality Complaint (PQC)
Location: Gurugram (Gurgaon), Haryana, India
Job ID: 25105574
Employment Type: Full-Time | Office-Based
Company: Syneos Health
About the Company
Syneos Health is a global biopharmaceutical solutions organization integrating clinical development, medical affairs, and commercialization services. Operating across 110+ countries, the company supports pharmaceutical, biotechnology, and medical device organizations in accelerating therapy development and ensuring regulatory compliance throughout the product lifecycle.
With extensive experience supporting novel FDA-approved drugs and EMA-authorized products, Syneos Health delivers high-quality pharmacovigilance, medical device safety, and regulatory services worldwide.
Job Overview
The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for end-to-end Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations.
This role requires hands-on experience in Product Quality Complaint (PQC) case handling, medical device vigilance, and clinical research safety case processing. The ideal candidate will ensure inspection readiness, regulatory accuracy, and data integrity in line with ICH-GCP, GVP, and global PV standards.
Experience Required
Total experience: 2.5 to 4 years in Pharmacovigilance or Drug Safety
Minimum 1 year of exclusive experience handling Product Quality Complaint (PQC) cases
Experience in medical research-related safety case processing
Hands-on experience in Argus and/or ARISg safety databases
Experience supporting Phase II–IV clinical trials and/or post-marketing safety activities preferred
Educational Qualifications
B.Pharm, M.Pharm, PharmD, BDS, BMS, or MBBS
B.Sc or M.Sc candidates are not eligible
Key Responsibilities
ICSR Processing and Case Management
Perform end-to-end processing of Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans
Enter and manage safety data within PV quality and tracking systems
Triage and assess cases for completeness, accuracy, and regulatory reportability
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and other relevant dictionaries
Prepare medically accurate and comprehensive case narratives
Identify duplicate cases and resolve inconsistencies through follow-up queries
Conduct quality review of processed ICSRs
Regulatory Reporting and Compliance
Support preparation and submission of expedited safety reports in compliance with global regulatory requirements
Validate and submit xEVMPD product records with appropriate MedDRA coding
Perform manual recoding of uncoded product and substance terms
Support SPOR and IDMP-related activities
Maintain safety tracking documentation for assigned activities
Ensure submission of relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF), as applicable
Apply regulatory intelligence to ongoing safety reporting processes
Medical Device Safety and PQC Handling
Manage Product Quality Complaint cases in alignment with medical device vigilance regulations
Collaborate with cross-functional teams to ensure accurate PQC documentation and compliance
Support safety evaluations related to device-related adverse events
Literature, Audit, and Quality Support
Perform literature screening and safety signal review
Maintain drug and device dictionaries
Ensure compliance with SOPs, Work Instructions, ICH-GCP, GVP, and global drug, biologic, and device regulations
Participate in internal audits and regulatory inspections
Support inspection readiness activities
Technical Skills and Knowledge
Strong understanding of global pharmacovigilance regulations including FDA, EMA, and ICH guidelines
Practical knowledge of clinical trial safety reporting and post-marketing surveillance
Experience with Argus or ARISg safety databases
Proficiency in MedDRA coding
Strong working knowledge of Microsoft Office applications
Core Competencies
High attention to detail and data accuracy
Strong analytical and problem-solving skills
Ability to manage multiple safety cases under strict timelines
Effective written and verbal communication skills
Ability to collaborate within cross-functional and global teams
Commitment to quality, compliance, and patient safety
Why Join Syneos Health
Exposure to global pharmacovigilance and medical device safety programs
Opportunity to work in a structured, compliance-driven environment
Career growth within global drug safety and regulatory operations
Participation in projects supporting life-saving therapies and medical innovations
Equal Opportunity Statement
Syneos Health is committed to providing equal employment opportunities and maintaining compliance with applicable global employment regulations. Reasonable accommodations will be provided where required to enable individuals to perform essential job functions.
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