Safety & Pharmacovigilance Specialist I – Medical Device & Product Quality Complaints (PQC)
Job ID: 25105574
Location: Gurugram, India (Office-Based)
Employment Type: Full-Time
Company: Syneos Health
Job Overview
Syneos Health is seeking a Safety & Pharmacovigilance Specialist I to support medical device vigilance and Product Quality Complaint (PQC) case management within its global pharmacovigilance operations team. This role focuses on end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with international drug and medical device safety regulations.
This opportunity is ideal for pharmacovigilance professionals with experience in PQC handling, safety database management, and global regulatory reporting across clinical and post-marketing environments.
Experience Required
2.5 to 4 years of experience in pharmacovigilance or drug safety operations
Minimum 1 year of exclusive experience handling Product Quality Complaint (PQC) cases
Experience managing medical research or clinical trial safety cases
Hands-on experience with Argus or ARISg safety databases
Working knowledge of global pharmacovigilance regulations (GVP, ICH-GCP, FDA, EMA guidelines)
Experience supporting Phase II–IV clinical trials and/or post-marketing safety programs
Educational Qualifications
B.Pharm
M.Pharm
PharmD
BDS
BMS
MBBS
(B.Sc and M.Sc candidates are not eligible.)
Key Responsibilities
ICSR Processing & Safety Case Management
Enter and track ICSRs in pharmacovigilance quality and tracking systems
Triage and evaluate safety cases for completeness, accuracy, and regulatory reportability
Process ICSRs in accordance with SOPs and project-specific safety plans
Enter case data into Argus / ARISg safety databases
Perform MedDRA coding for adverse events, medical history, concomitant medications, and laboratory tests
Prepare medically accurate and comprehensive case narratives
Identify missing or inconsistent information and follow up for resolution
Detect and manage duplicate ICSRs
Conduct quality review of safety cases
Regulatory Reporting & Compliance
Support preparation and submission of expedited safety reports in compliance with global regulatory timelines
Validate and submit xEVMPD product records, including MedDRA-coded indication terms
Perform manual recoding of uncoded product and substance terms
Contribute to SPOR / IDMP-related regulatory activities
Ensure submission of safety documentation to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF), where applicable
Apply regulatory intelligence updates to safety reporting processes
Literature, Audit & Quality Support
Conduct literature screening and safety review activities
Maintain drug dictionaries and coding standards
Ensure compliance with SOPs, Work Instructions, GCP, ICH guidelines, and global drug/biologic/device regulations
Support audit readiness and regulatory inspection activities
Collaborate with internal teams and external stakeholders to maintain compliance standards
Core Competencies
Strong knowledge of medical device vigilance and pharmacovigilance regulations
Expertise in Product Quality Complaint case handling
High attention to detail and data accuracy
Strong organizational and prioritization skills
Ability to work in deadline-driven, compliance-focused environments
Proficiency in Microsoft Office applications
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development and commercialization success. Operating in over 110 countries with more than 29,000 professionals, the company supports pharmaceutical, biotechnology, and medical device clients through clinical, medical affairs, and commercial expertise.
In the past five years, Syneos Health has supported the development of the majority of newly approved FDA and EMA therapies, reinforcing its leadership in global clinical research and pharmacovigilance services.
Why Join Syneos Health?
Opportunity to work on global pharmacovigilance and medical device safety programs
Structured career development and professional growth pathways
Exposure to international regulatory standards and inspection readiness initiatives
Collaborative and compliance-driven work culture
This Safety & Pharmacovigilance Specialist I – Medical Device & PQC role in Gurugram is ideal for experienced drug safety professionals seeking to advance their careers in medical device vigilance, ICSR processing, and global regulatory reporting.
Apply now through The Pharma Daily to explore pharmacovigilance and product quality safety jobs with leading global biopharmaceutical organizations.
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