ProductLife Group (PLG) is hiring experienced Pharmacovigilance professionals for the position of Case Specialist (Clinical Trial Cases) in India. This permanent opportunity is suitable for qualified doctors and pharmacists with strong experience in clinical trial case processing, ICSR quality control, medical evaluation, and drug safety databases such as Oracle Argus Safety and SafetyEasy.
The role offers an opportunity to work in the Safety and Vigilance function, supporting the management and quality review of clinical trial safety cases. Remote work may also be possible depending on business and operational requirements.
Job Highlights
- Company: ProductLife Group (PLG)
- Job Title: Case Specialist (Clinical Trial Cases)
- Department: Life Cycle – Safety and Vigilance
- Job Location: India
- Work Mode: Remote work possible
- Employment Type: Permanent
- Experience Required: Minimum 4 years
- Clinical Trial Case Processing Experience: Minimum 3 years
- Qualification: Doctor or Pharmacist by training
- Database Skills: SafetyEasy / Oracle Argus preferred
- Salary: Estimated ₹8–15 LPA (depending on experience and skills)
About the ProductLife Group Case Specialist Role
The Case Specialist (Pharmacovigilance) will contribute to the processing, medical evaluation, quality control, and management of vigilance cases, particularly clinical trial cases.
This role requires strong knowledge of pharmacovigilance regulations, Individual Case Safety Reports (ICSRs), medical assessment, adverse event evaluation, case coding, causality assessment, seriousness assessment, and safety reporting requirements.
Candidates with hands-on experience in clinical trial safety, case processing, QC of safety cases, Oracle Argus Safety, SafetyEasy, and regulatory compliance may find this opportunity particularly relevant.
Key Responsibilities
As a Case Specialist, the selected candidate will be responsible for:
- Performing quality control of pharmacovigilance and vigilance cases.
- Conducting medical evaluation of safety reports.
- Processing and entering vigilance case information into databases and client-approved systems.
- Managing data entry activities for clinical trial safety cases.
- Conducting follow-up activities through phone calls and email communication.
- Performing pre-analysis of complex cases before data entry.
- Reviewing and evaluating medical information associated with vigilance cases.
- Performing medical coding according to applicable dictionaries.
- Assessing the causal relationship between reported effects and suspected products.
- Evaluating whether events are expected/listed or unexpected/unlisted.
- Assessing the seriousness of adverse events, effects, incidents, and safety cases.
- Identifying regulatory and operational submission requirements for individual cases.
- Reviewing and validating documents prepared by Data Managers, Vigilance Associates, and other team members.
- Supporting the closure of vigilance and safety files.
- Identifying applicable requirements and changes for ICSR and MLM filters.
- Reviewing the inclusion and exclusion of EV/MHRA cases.
- Providing medical information support when required.
- Supporting client-specific pharmacovigilance and safety activities within the Business Unit.
- Maintaining compliance with applicable pharmacovigilance regulations and internal procedures.
Eligibility Criteria
Educational Qualification
ProductLife Group has specified the following educational background:
- Doctor by training, or
- Pharmacist by training
Candidates with professional qualifications and relevant backgrounds in areas such as Pharmacy, Medicine, Pharmacovigilance, Clinical Research, Drug Safety, and related life sciences may be relevant depending on whether they meet the employer’s specific professional qualification requirements.
Experience Required
Candidates should have:
- A minimum of 4 years of experience working with service providers and performing quality control of safety cases.
- At least 3 years of experience processing clinical trial cases.
- Practical experience in pharmacovigilance case processing and medical evaluation.
Required Skills
The ideal candidate should possess knowledge and experience in:
- Pharmacovigilance
- Clinical Trial Safety
- Clinical Trial Case Processing
- ICSR Processing
- Safety Case Quality Control
- Medical Evaluation
- Adverse Event Assessment
- Seriousness Assessment
- Causality Assessment
- Medical Coding
- Drug Safety Regulations
- Oracle Argus Safety
- SafetyEasy Database
- Safety Case Follow-up
- Regulatory Compliance
- Microsoft Office
Database Experience
Experience with the following pharmacovigilance databases is specifically preferred:
- SafetyEasy
- Oracle Argus Safety
Candidates with experience working on drug safety databases and electronic case management systems may have an advantage.
Additional Candidate Profile
ProductLife Group is looking for candidates who demonstrate:
- Knowledge of current pharmacovigilance regulations.
- Strong process orientation.
- Attention to detail and accuracy.
- Ability to work effectively within a team.
- Strong multitasking abilities.
- Flexibility and adaptability.
- Good knowledge of Microsoft Office applications.
- Excellent business communication skills.
- Professional communication skills in English and French for business continuity.
Who Should Apply?
This ProductLife Group Pharmacovigilance job in India may be suitable for experienced professionals working in:
- Pharmacovigilance
- Drug Safety
- Clinical Trial Safety
- ICSR Processing
- Safety Case Processing
- Safety Case Quality Control
- Medical Review
- Clinical Research
- CRO Pharmacovigilance Operations
Candidates with several years of experience in clinical trial case processing and safety case QC are particularly relevant for this position.
Salary and Compensation
ProductLife Group has not disclosed the official salary for this position.
Based on the experience requirements, specialized pharmacovigilance responsibilities, clinical trial safety expertise, and database experience required, the estimated salary range for this role in India may be approximately ₹8–15 lakh per annum (LPA).
Actual compensation may vary based on:
- Total professional experience
- Pharmacovigilance expertise
- Clinical trial safety experience
- Oracle Argus or SafetyEasy experience
- Medical or pharmacy qualifications
- Language skills
- Location and employment terms
Note: The salary range above is an editorial estimate by Pharmabharat and is not an officially disclosed salary from ProductLife Group.
Why Consider This Pharmacovigilance Opportunity?
This role provides experienced drug safety professionals with the opportunity to work on complex clinical trial cases and contribute to critical pharmacovigilance activities.
The position offers exposure to areas including:
- Clinical trial safety operations
- Medical evaluation
- Safety case quality control
- Regulatory reporting
- ICSR management
- Pharmacovigilance databases
- International safety processes
For professionals looking to advance their careers in pharmacovigilance, drug safety, clinical research, and clinical trial safety, this role offers specialized responsibilities within an established life sciences services environment.
How to Apply
