ProPharma is hiring for the role of Pharmacovigilance Specialist โ Submissions in India. This is an excellent opportunity for candidates with a life sciences background (B.Pharm, M.Pharm, Pharm.D, BSc, MSc) who want to build a career in pharmacovigilance and drug safety.
With over 20 years of global expertise, ProPharma supports biotech, pharmaceutical, and medical device companies across regulatory, clinical, and safety domains. This role focuses on adverse event reporting, ICSR submissions, and regulatory compliance, making it highly relevant for candidates targeting pharmacovigilance jobs in India.
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Job Overview
- Role: Pharmacovigilance Specialist โ Submissions
- Company: ProPharma
- Location: India (Remote/Hybrid)
- Job Type: Full-Time
- Experience: Preferred (Freshers with relevant skills may apply)
Key Responsibilities
Adverse Event & ICSR Submissions
- Monitor and track ICSR submissions (expedited & non-expedited)
- Ensure compliance with health authorities and safety partners
- Perform monthly reconciliation of adverse event reports
- Support gateway submissions testing (E2B compliance)
Periodic Safety Reports
- Generate line listings and summary tabulations
- Assist in Periodic Safety Update Reports (PSUR/PBRER)
- Verify regulatory reporting requirements
Submission & Argus Projects
- Work on Oracle Argus Safety database
- Participate in performance qualification (PQ) testing
- Support data migration and system upgrades
- Maintain E2B profiles for new territories/products
Required Qualifications
- Education: Life sciences degree preferred (B.Pharm, M.Pharm, Pharm.D, MSc, BSc)
- Skills:
- Strong understanding of pharmacovigilance submissions
- Knowledge of ICSR, E2B, and regulatory reporting
- Proficiency in Microsoft Excel, Word, Outlook
- High attention to detail and accuracy
- Language: Fluent English (written & verbal)
- Experience: Prior pharmacovigilance experience preferred
Why Join ProPharma? (Benefits)
- Work with a global pharmacovigilance leader
- Exposure to Argus Safety and regulatory systems
- Opportunity in remote/hybrid work model
- Career growth in drug safety & regulatory affairs
- Inclusive and diversity-driven work culture
How to Apply
