Safety & Pharmacovigilance Specialist I – Medical Device & Product Quality
Job ID: 25103553
Location: Gurugram / Hyderabad, India (Office-Based)
Employment Type: Full-Time
Company: Syneos Health
Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I to support medical device vigilance and product quality complaint (PQC) case management within its global drug safety operations team. This role is ideal for experienced pharmacovigilance professionals with hands-on expertise in ICSR processing, product quality complaint handling, and regulatory safety reporting.
The selected candidate will play a critical role in ensuring compliance with global pharmacovigilance regulations, maintaining data accuracy in safety databases, and supporting regulatory submissions across clinical and post-marketing environments.
Experience Required
2.5 to 4 years of relevant pharmacovigilance experience
Minimum 1 year of exclusive experience handling Product Quality Complaint (PQC) cases
Experience managing medical research safety cases
Hands-on experience with Argus or ARISg safety database systems
Exposure to clinical trial and/or post-marketing safety reporting
Strong understanding of global pharmacovigilance regulations including GVP and ICH-GCP
Educational Qualifications
B.Pharm
M.Pharm
PharmD
BDS
BMS
MBBS
(B.Sc and M.Sc candidates are not eligible for this role.)
Key Responsibilities
ICSR Processing & Case Management
Perform end-to-end Individual Case Safety Report (ICSR) processing and quality review
Conduct medical coding for adverse events, medical history, concomitant medications, and laboratory data
Prepare comprehensive case narratives and manage follow-up queries
Identify and reconcile duplicate ICSRs
Maintain safety tracking systems to ensure timely regulatory submissions
Product Quality & Medical Device Vigilance
Handle Product Quality Complaint (PQC) cases in compliance with regulatory and client requirements
Support medical device vigilance reporting and related safety assessments
Ensure adherence to global safety standards for medical devices and combination products
Regulatory Compliance & Submissions
Support xEVMPD validation and submission activities
Contribute to SPOR / IDMP-related initiatives
Ensure compliance with SOPs, Global Pharmacovigilance Practices (GVP), ICH-GCP, and international regulatory frameworks
Support audit readiness activities and regulatory inspections
Core Skills & Competencies
Strong knowledge of global drug safety and pharmacovigilance regulations
High level of accuracy and compliance-driven mindset
Strong organizational and prioritization skills
Ability to work in deadline-driven, regulated environments
Effective stakeholder communication and coordination skills
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and commercialization outcomes. With operations across more than 110 countries and a workforce of over 29,000 professionals, the company supports pharmaceutical, biotechnology, and medical device organizations through clinical, medical affairs, and commercial solutions.
Over the past five years, Syneos Health has supported the development of the majority of newly approved FDA and EMA therapies, reinforcing its position as a global leader in clinical research and pharmacovigilance services.
Why Join Syneos Health?
Exposure to global pharmacovigilance and medical device safety operations
Structured career development and progression opportunities
Collaborative and compliance-focused work culture
Opportunity to work on innovative therapies and medical technologies
This Safety & Pharmacovigilance Specialist I position in Gurugram / Hyderabad is an excellent opportunity for pharmacovigilance professionals seeking to advance their careers in product quality complaint management, medical device vigilance, and global regulatory safety compliance.
Apply now through The Pharma Daily to explore pharmacovigilance and medical device safety jobs in India with leading global biopharmaceutical organizations.
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