Case Specialist – Pharmacovigilance (Safety & Vigilance)
Job ID: 506
Location: India (Remote / Work from Home Eligible)
Employment Type: Permanent
Functional Area: Pharmacovigilance | Drug Safety | Life Cycle Management
Industry: Life Sciences / Pharmaceutical Services
Job Overview
ProductLife Group is seeking a Case Specialist (Pharmacovigilance) to join its Safety and Vigilance team. This role plays a critical part in ensuring the medical accuracy, regulatory compliance, and quality control of individual case safety reports (ICSRs) across global pharmacovigilance operations.
The ideal candidate will bring strong scientific judgment, hands-on safety case processing experience, and a thorough understanding of global PV regulations to support end-to-end vigilance activities.
Key Responsibilities
Pharmacovigilance Case Management
Perform quality control (QC) of pharmacovigilance cases in accordance with internal procedures and regulatory requirements.
Conduct medical evaluation and assessment of safety reports, including complex and high-risk cases.
Perform data entry and validation of vigilance cases in client-approved safety databases or agreed formats.
Initiate and manage case follow-ups via phone or email to obtain missing or clarifying safety information.
Conduct pre-analysis of complex cases prior to case entry and submission.
Medical Review and Regulatory Assessment
Perform medical evaluation related to:
Coding of adverse events using applicable medical dictionaries
Causality assessment between suspect product(s) and reported events
Determination of expectedness (listed vs. unlisted events)
Seriousness classification of events and cases
Identification of regulatory submission requirements per case
Review and validate documentation produced by Data Managers, Vigilance Associates, or Documentation Specialists.
Support case closure activities ensuring accuracy, completeness, and audit readiness.
Compliance, Reporting, and Safety Intelligence
Identify and implement requirements for ICSR and MLM filtering, including regulatory updates and client-specific changes.
Analyze inclusion and exclusion criteria for EudraVigilance (EV) and MHRA cases.
Support medical information activities by identifying safety-relevant content from inquiries and quality complaints.
Respond to incoming calls that generate safety notifications and assess safety relevance.
Act as a key point of contact for assigned clients, in coordination with Activity Managers or Line Managers.
Documentation and Process Improvement
Author, review, and maintain quality documents and SOPs related to pharmacovigilance activities.
Contribute to client-specific process documentation and continuous improvement initiatives.
Required Qualifications and Experience
Education
Doctor of Pharmacy (PharmD) or Registered Pharmacist qualification is mandatory
Experience
1–3 years of experience in pharmacovigilance, drug safety, or safety case processing
Prior experience in ICSR processing, medical review, or safety data quality control preferred
Working knowledge of global pharmacovigilance regulations is an advantage
Key Skills and Competencies
Experience working with pharmacovigilance or safety databases
Strong understanding of global PV regulations and reporting requirements
High attention to detail with a quality- and process-oriented mindset
Ability to manage multiple cases and priorities in a deadline-driven environment
Proficiency in Microsoft Office applications
Strong written and verbal communication skills
Fluency in English and French is required to support global business continuity
Ability to work independently as well as collaboratively within cross-functional teams
Why Join ProductLife Group
ProductLife Group is a global life sciences consulting and services organization supporting pharmaceutical, biotech, and medical device companies across the entire product lifecycle. Joining PLG means working in a collaborative, international environment focused on quality, compliance, and patient safety.
Equal Opportunity Statement
ProductLife Group is committed to diversity, inclusion, and equal employment opportunities for all qualified candidates.
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