Safety & PV Specialist I - Medical Device & PQC
Company: Syneos Health
Location: Hyderabad, India (Office-Based)
Employment Type: Full-Time
Job Title: Safety & Pharmacovigilance Specialist I
Experience Required: 2.5 – 4 Years
Job Summary
The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations. The role requires expertise in Product Quality Complaint (PQC) case handling and experience with medical research safety cases.
Key Responsibilities
ICSR Processing & Case Management
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs according to SOPs and project-specific safety plans.
Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability.
Enter case data into safety databases such as Argus / ARISg.
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant dictionaries.
Prepare comprehensive and medically accurate narrative summaries.
Identify missing or inconsistent information and follow up on queries.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Regulatory Reporting & Compliance
Support preparation and submission of expedited safety reports according to global regulatory requirements.
Validate and submit xEVMPD product records.
Perform manual recoding of uncoded product and substance terms.
Support SPOR / IDMP activities.
Maintain safety tracking activities.
Ensure submission of relevant documents to:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Literature, Audit & Collaboration
Perform literature screening and safety review.
Maintain drug dictionaries and support coding activities.
Ensure compliance with:
SOPs
Work Instructions (WIs)
GCP
ICH Guidelines
GVP
Global drug, biologic, and device regulations
Participate in audits and inspection readiness activities.
Maintain professional relationships with internal and external stakeholders.
Required Qualifications
Education:
B.Pharm
M.Pharm
PharmD
BDS
BMS
MBBS
(B.Sc / M.Sc not eligible)
Minimum 1 year of Product Quality Complaint (PQC) case handling experience.
Experience handling medical research-related safety cases.
Hands-on experience with Argus / ARISg safety database.
Strong knowledge of pharmacovigilance regulations and reporting requirements.
Understanding of clinical trial phases II–IV and post-marketing safety.
Proficiency in Microsoft Office applications.
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