Safety & PV Specialist I - PQC
Company: Syneos Health
Location: Gurgaon, India
Job ID: 25107950
Employment Type: Full-Time
Work Mode: Office-Based
Experience Required: 2.5 – 4 Years
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress.
Syneos Health focuses on:
Clinical development solutions
Medical affairs
Commercial insights
Patient-focused healthcare innovation
Job Summary
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
Compliance with global pharmacovigilance regulations
Product Quality Complaint (PQC) case handling
Medical research-related safety case processing
Key Responsibilities
ICSR Processing & Case Management
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
Triage ICSRs and evaluate:
Completeness
Accuracy
Regulatory reportability
Enter case data into safety databases such as:
Argus
ARISg
Perform coding of:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Code using:
MedDRA
Relevant medical dictionaries
Prepare accurate medical narrative summaries.
Identify missing or inconsistent information.
Follow up on queries until resolution.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Regulatory Reporting & Compliance
Support preparation and submission of expedited safety reports.
Ensure reporting activities comply with global regulatory requirements.
Validate and submit xEVMPD product records.
Perform MedDRA coding of indication terms.
Perform manual recoding of uncoded product and substance terms.
Support SPOR / IDMP activities.
Maintain safety tracking activities.
Ensure documentation submission to:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Apply safety reporting regulatory intelligence.
Maintain compliance with:
SOPs
Work Instructions (WIs)
GCP
ICH guidelines
GVP regulations
Global drug, biologic, and device regulations
Literature, Audit & Collaboration
Perform literature screening and safety reviews.
Maintain drug dictionaries.
Support coding activities.
Participate in audits and inspection readiness activities.
Maintain professional relationships with:
Internal teams
External stakeholders
Project partners
Required Qualifications
Education
Eligible qualifications:
B.Pharm
M.Pharm
PharmD
BDS
BMS
MBBS
Not eligible:
B.Sc
M.Sc
Required Experience & Skills
Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
Experience handling medical research-related safety cases.
Hands-on experience with:
Argus safety database
ARISg safety database
Strong understanding of:
Pharmacovigilance regulations
Safety reporting requirements
Knowledge of:
Clinical trial phases II–IV
Post-marketing safety
Proficiency in Microsoft Office applications.
About Syneos Health
Syneos Health has supported:
94% of Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000 sites
675,000+ clinical trial patients
The organization promotes:
Career development
Technical training
Inclusive workplace culture
Global collaboration
Equal Opportunity Statement
Syneos Health is committed to building a diverse and inclusive workplace. The company provides equal employment opportunities and reasonable accommodations for qualified individuals with disabilities.
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