Unichem Laboratories is inviting applications for the position of Officer โ Pharmacovigilance (Quality & Literature Review) at its Mumbai (Kandivali) location. This is an excellent opportunity for experienced Pharmacovigilance professionals with expertise in literature review, Argus Safety Database, aggregate reporting, and global pharmacovigilance operations.
Candidates with 2โ5 years of Pharmacovigilance experience and qualifications in B.Pharm or M.Pharm are encouraged to apply.
Job Overview
| Particular | Details |
|---|---|
| Company | Unichem Laboratories |
| Job Title | Officer โ Pharmacovigilance โ Quality & Literature Review |
| Job Location | Mumbai (Kandivali), Maharashtra |
| Experience | 2โ5 Years |
| Employment Type | Full-Time |
| Department | Pharmacovigilance |
| Qualification | B.Pharm / M.Pharm |
| Industry | Pharmaceutical & Life Sciences |
Key Responsibilities
The selected candidate will be responsible for supporting global Pharmacovigilance activities, including:
- Review scientific literature for adverse event validity.
- Perform literature screening and maintain search records.
- Conduct case triage and booking in Argus Safety Database.
- Perform case data entry in Argus when required.
- Execute quality review of safety cases.
- Conduct EudraVigilance ICSR screening.
- Prepare and review aggregate safety reports including PADERs.
- Develop and maintain Pharmacovigilance SOPs and Work Instructions.
- Deliver Pharmacovigilance training to internal teams and stakeholders.
- Manage global regulatory safety submissions.
- Oversee case processing quality activities.
- Coordinate reconciliation activities with QPPVs, partners, distributors and marketing authorization holders.
- Respond to Pharmacovigilance-related queries from internal and external stakeholders.
- Support additional Pharmacovigilance activities assigned by supervisors.
Required Qualifications
Applicants should possess:
- B.Pharm in any specialization
- M.Pharm in any specialization
Required Skills
The ideal candidate should have:
- Pharmacovigilance experience
- Literature Screening
- Argus Safety Database
- Quality Review
- EudraVigilance
- ICSR Management
- Aggregate Report Preparation
- PADER Preparation
- SOP Development
- Work Instruction Management
- Global Safety Submissions
- Reconciliation Activities
- GVP Guidelines
- Good Documentation Practices
- Excellent Communication Skills
- Basic Computer Knowledge
Preferred Experience
Candidates with exposure to the following will have an advantage:
- Good knowledge of Good Pharmacovigilance Practices (GVP Modules)
- Aggregate safety reporting
- Global Pharmacovigilance operations
- Safety database quality review
- Regulatory compliance
Why Join Unichem Laboratories?
Joining Unichem Laboratories offers:
- Opportunity to work in a reputed global pharmaceutical organization
- Exposure to international Pharmacovigilance processes
- Experience with Argus Safety Database
- Hands-on involvement in aggregate reporting and global submissions
- Learning and development opportunities
- Strong work-life balance
- Career growth in Drug Safety and Pharmacovigilance
Eligibility
Candidates who meet the following criteria are encouraged to apply:
- 2โ5 years of Pharmacovigilance experience
- Experience in literature review and quality review
- Familiarity with Argus Safety Database
- Knowledge of GVP Modules
- B.Pharm or M.Pharm qualification
How to Apply
