Safety & PV Specialist I (Night Shift)
Company: Syneos Health
Location: Gurugram, Haryana, India
Job ID: 25107948
Employment Type: Full-Time
Shift: Night Shift
Department: Pharmacovigilance / Drug Safety
Job Summary
The Safety & PV Specialist I is responsible for supporting pharmacovigilance operations including the intake, processing, quality review, and regulatory reporting of Individual Case Safety Reports (ICSRs). The role ensures compliance with global safety regulations, SOPs, and pharmacovigilance systems while maintaining high-quality safety data for clinical and post-marketing programs.
Key Responsibilities
ICSR Processing & Case Management
Enter and track safety information in PV quality and tracking systems.
Process ICSRs in accordance with SOPs and project-specific safety plans.
Triages ICSRs and assess data for completeness, accuracy, and reportability.
Prepare narrative case summaries for safety reports.
Data Entry & Coding
Enter case data into safety databases.
Code medical events, medical history, concomitant medications, and laboratory tests using MedDRA.
Perform manual recoding of product and substance terms as required.
Maintain accuracy in coding using standardized dictionaries.
Safety Reporting & Compliance
Support timely submission of expedited safety reports in line with regulatory requirements.
Ensure compliance with GVP, GCP, ICH guidelines, and internal SOPs.
Maintain understanding of global drug safety regulations and reporting standards.
Ensure appropriate documentation is filed in TMF and PV systems.
Quality Review & Data Integrity
Perform quality review of ICSRs.
Identify duplicate cases and manage case reconciliation.
Conduct literature screening for safety information.
Support xEVMPD submissions and IDMP/SPOR-related activities.
Regulatory & Operational Support
Assist in maintenance of drug dictionaries and MedDRA updates.
Apply regulatory intelligence to safety reporting activities.
Participate in audits and inspection readiness activities.
Maintain safety tracking systems for assigned projects.
Stakeholder Collaboration
Collaborate with internal and external project teams.
Maintain professional working relationships across global teams.
Support cross-functional pharmacovigilance operations.
Required Qualifications
Education
Bachelor’s Degree in:
Pharmacy (B.Pharm / M.Pharm)
Dental Surgery (BDS)
Biomedical Sciences (BMS)
Medicine (MBBS)
Note: BSc / MSc candidates are not eligible.
Experience
Minimum 2.6 years of experience in Pharmacovigilance / Drug Safety operations.
Experience in:
ICSR processing
MedDRA coding
Safety database handling
Regulatory reporting
Literature screening
Technical Skills
Strong knowledge of:
Pharmacovigilance systems
MedDRA coding standards
Drug safety databases
GVP, GCP, ICH guidelines
Experience in xEVMPD, SPOR, IDMP (preferred).
Understanding of clinical trial and post-marketing safety processes.
Key Skills
Attention to detail
Data accuracy and quality focus
Regulatory compliance understanding
Strong documentation skills
Analytical and problem-solving ability
Time management under strict deadlines
Work Requirements
Willingness to work in night shifts (mandatory).
Office-based role in Gurugram.
Immediate or early joiners preferred.
Key Contribution
Ensure accurate and compliant pharmacovigilance case processing.
Support global drug safety surveillance systems.
Contribute to regulatory compliance and patient safety.
Maintain high-quality safety data supporting clinical and post-marketing decisions.
Salary Criteria
Expected Salary: ₹4.5–7.5 LPA for candidates with 2.5–5 years of Pharmacovigilance experience in ICSR processing, MedDRA coding, and safety database operations; candidates with strong regulatory system exposure (xEVMPD, SPOR, IDMP) may earn ₹7.5–9 LPA depending on expertise and night-shift experience.
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