Case Specialist – Pharmacovigilance
Job ID: 506
Location: India (Remote Work Possible)
Employment Type: Permanent
Function: Safety & Vigilance | Life Cycle Management
Experience Level: Junior to Mid-Level (1–3 Years)
About ProductLife Group
ProductLife Group (PLG) is a global life sciences consulting firm providing integrated expertise across the entire product lifecycle. With a strong presence in pharmacovigilance, regulatory affairs, and medical services, PLG partners with pharmaceutical, biotechnology, and medical device companies worldwide to ensure compliance, quality, and patient safety.
Position Overview
ProductLife Group is seeking a Case Specialist – Pharmacovigilance to join its Safety and Vigilance Hub. The role involves end-to-end case management activities, quality control of vigilance cases, and medical evaluation in compliance with global pharmacovigilance regulations. This position offers an excellent opportunity to grow within a dynamic, international PV environment.
Key Responsibilities
Perform quality control reviews of pharmacovigilance cases (ICSRs)
Conduct medical evaluation of safety reports
Perform accurate data entry of vigilance cases into client-approved databases
Manage follow-up activities via phone and email with reporters and stakeholders
Pre-analyze complex cases prior to data entry
Conduct medical assessments related to:
Coding using applicable medical dictionaries
Causality assessment between suspect products and reported events
Expectedness (listed/unlisted events)
Seriousness classification and overall case evaluation
Identify global submission requirements for each case
Validate documentation prepared by Vigilance Associates, Data Managers, or Documentalists
Ensure timely closure of vigilance cases
Support setup and maintenance of ICSR/MLM filters
Analyze inclusion and exclusion criteria for EV and MHRA cases
Provide medical support to the Medical Information function
Handle incoming safety notification calls
Review medical information inquiries and quality complaints to detect safety signals
Act as key contact for assigned clients with managerial support
Develop and maintain quality and procedural documents relevant to assigned activities
Education & Experience Requirements
Doctor of Pharmacy (PharmD) or Graduate Pharmacist qualification
1–3 years of experience in pharmacovigilance or a related drug safety role
Prior experience in case processing or safety data management is preferred
Knowledge of pharmacovigilance regulations and processes is an advantage
Required Skills & Competencies
Hands-on experience with safety databases preferred
Strong knowledge of global pharmacovigilance regulations
High attention to detail and strong quality orientation
Ability to work effectively in a team-based environment
Proficiency in Microsoft Office tools
Strong multitasking and organizational skills
Flexible and adaptable to changing priorities
Excellent verbal and written communication skills in English and French
Why Join ProductLife Group
Work with a global leader in pharmacovigilance and life sciences consulting
Opportunity to work remotely with international clients
Exposure to global regulatory environments
Career growth in a structured and quality-driven organization
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