Pharmacovigilance Specialist - ICSR & PQC

Why This Role Matters
The Safety & Pharmacovigilance Specialist I plays an important role in maintaining patient safety and regulatory compliance by managing Individual Case Safety Reports (ICSRs), handling Product Quality Complaints (PQC), and supporting global pharmacovigilance reporting activities. This role contributes to ensuring that safety data is accurately captured, evaluated, and reported in compliance with international regulations, ultimately helping protect patients and support the safe use of therapies worldwide.

Job Description
The Safety & PV Specialist I is responsible for end-to-end pharmacovigilance case processing, safety data management, and regulatory reporting support. The role involves managing ICSRs, performing quality reviews, coding medical data using MedDRA, preparing narratives, and supporting safety compliance activities. The position also includes literature screening, audit support, and collaboration with global teams to ensure adherence to regulatory standards and safety procedures.

Key Features of the Role
• Manage end-to-end ICSR processing and safety case management.
• Enter and track safety information within pharmacovigilance databases.
• Perform case triage to evaluate completeness and regulatory reportability.
• Code adverse events, medications, and medical history using MedDRA and related dictionaries.
• Prepare medically accurate narrative summaries for safety cases.
• Identify missing or inconsistent information and follow up for resolution.
• Perform quality review of ICSRs and manage duplicate case identification.
• Support preparation and submission of expedited regulatory safety reports.
• Maintain safety documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
• Support xEVMPD product record validation and SPOR/IDMP-related activities.
• Conduct literature screening and safety monitoring activities.
• Participate in audits and support inspection readiness.
• Maintain compliance with SOPs, GCP, ICH guidelines, GVP, and global safety regulations.

Responsibilities
• Process and manage Individual Case Safety Reports (ICSRs).
• Perform coding of medical data using MedDRA and maintain drug dictionaries.
• Prepare narrative summaries and evaluate safety case completeness.
• Assist in regulatory safety reporting and global compliance activities.
• Manage Product Quality Complaint (PQC) safety cases.
• Maintain pharmacovigilance documentation and regulatory records.
• Collaborate with internal and external stakeholders to support safety operations.

Required Qualifications
• B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS
• Minimum 2.5–4 years of experience in pharmacovigilance or drug safety roles
• At least 1 year of exclusive experience handling Product Quality Complaint (PQC) cases
• Hands-on experience with safety databases such as Argus or ARISg
• Knowledge of global pharmacovigilance regulations and reporting requirements

Educational Requirements
• Bachelor’s or Master’s degree in pharmacy, medicine, dentistry, or related healthcare field

Experience and Skills
• Strong experience in ICSR processing and pharmacovigilance case management
• Knowledge of MedDRA coding and safety data evaluation
• Understanding of clinical trial phases II–IV and post-marketing safety surveillance
• Familiarity with regulatory safety reporting requirements
• Experience with pharmacovigilance databases such as Argus or ARISg
• Strong analytical, communication, and documentation skills
• Ability to work with cross-functional global teams

Salary Insights
• Salary not specified; compensation is typically aligned with industry standards for pharmacovigilance specialists in India.

Company Overview
Syneos Health is a global biopharmaceutical solutions organization providing clinical, medical affairs, and commercial services to accelerate the development and commercialization of therapies. The company operates across more than 110 countries and collaborates with leading pharmaceutical and biotechnology organizations to bring innovative treatments to patients worldwide.

FAQs
• Where is the job location?
Gurugram, Haryana, India.

• What experience is required?
2.5–4 years in pharmacovigilance, including Product Quality Complaint (PQC) case handling.

• Which safety databases are required?
Experience with Argus or ARISg safety databases.

• Is clinical trial safety experience required?
Yes, knowledge of clinical trial safety (Phases II–IV) or post-marketing pharmacovigilance is preferred.

Application Tips
• Highlight experience in ICSR processing and pharmacovigilance workflows.
• Emphasize knowledge of MedDRA coding and global safety reporting requirements.
• Mention hands-on experience with safety databases such as Argus or ARISg.
• Showcase experience managing Product Quality Complaint (PQC) cases.
• Include examples of audit participation, regulatory submissions, or compliance support.