Safety & PV Specialist I & II – Pharmacovigilance
Company: Syneos Health
Department: Safety & Pharmacovigilance
Location: Hyderabad, India
Work Location: Office-Based
Employment Type: Full-Time
Job ID: 25110715
Experience Required:
Safety & PV Specialist I: Minimum 2.6 Years
Safety & PV Specialist II: Minimum 4 Years
Job Summary
The Safety & PV Specialist I & II role is responsible for Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting support, medical coding, literature review, and pharmacovigilance compliance activities. The role ensures accurate, timely, and compliant safety reporting in accordance with global regulatory requirements, company SOPs, and project-specific safety plans.
Key Responsibilities
ICSR Processing & Case Management
Enter safety case information into PV quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
Perform ICSR triage and evaluate case data for:
Completeness
Accuracy
Regulatory reportability
Enter case information into safety databases.
Perform coding activities for:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Prepare complete and medically accurate narrative summaries.
Identify missing or inconsistent information and manage follow-up queries until resolution.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Regulatory Reporting & Compliance
Support generation of timely, consistent, and accurate expedited safety reports.
Maintain safety tracking activities for assigned projects.
Ensure compliance with:
Global pharmacovigilance regulations
GCP requirements
ICH guidelines
GVP guidelines
Drug, biologic, and medical device safety regulations
Apply safety reporting regulatory intelligence to assigned activities.
Participate in audits and inspection readiness activities.
Medical Coding & Safety Database Activities
Perform MedDRA coding activities.
Support drug dictionary maintenance.
Perform literature screening and safety review.
Validate and submit xEVMPD product records.
Perform appropriate MedDRA coding of indication terms.
Conduct manual recoding of uncoded product and substance terms from ICSRs.
Support SPOR / IDMP-related activities.
Documentation Management
Ensure safety documents are submitted and maintained in:
Trial Master File (TMF) for clinical trials
Pharmacovigilance System Master File (PSMF) for post-marketing programs
Maintain accurate safety documentation according to sponsor requirements and company SOPs.
Support quality and compliance documentation activities.
Stakeholder Collaboration
Develop professional working relationships with:
Project teams
Internal stakeholders
External partners
Sponsors
Collaborate effectively to ensure timely completion of PV activities.
Support process improvement initiatives within pharmacovigilance operations.
Required Qualifications
Educational Qualification
Eligible qualifications:
B.Pharm
M.Pharm
BDS
BMS
MBBS
Not Eligible:
B.Sc
M.Sc
Experience Requirements
Safety & PV Specialist I
Minimum 2.6 years of pharmacovigilance experience.
Experience in ICSR processing and safety database activities.
Safety & PV Specialist II
Minimum 4 years of pharmacovigilance experience.
Strong experience in case processing, quality review, and regulatory safety activities.
Required Skills
Strong understanding of the pharmacovigilance lifecycle.
Hands-on experience with ICSR processing.
Knowledge of MedDRA coding.
Understanding of global PV regulations.
Knowledge of GCP, ICH, and GVP requirements.
Strong attention to detail and quality focus.
Ability to manage multiple cases and deadlines.
Good written and verbal communication skills.
Proficiency in Microsoft Office applications.
Preferred Experience
Experience with Argus Safety, ARISg, or similar pharmacovigilance databases.
Experience in clinical trial safety and post-marketing surveillance.
Knowledge of:
xEVMPD
SPOR
IDMP processes
Experience with literature screening and drug coding.
Experience handling complex global safety cases.
Estimated Salary Package (India)
Safety & PV Specialist I (2.6+ Years Experience)
₹6 – ₹10 LPA
Safety & PV Specialist II (4+ Years Experience)
₹9 – ₹15 LPA
Candidates with strong Argus expertise, MedDRA coding experience, global case processing exposure, and regulatory submission knowledge may receive higher compensation packages.
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