Pharmacovigilance Specialist – Submissions
Location: India (Hybrid/Remote)
Job Type: Full-time
Job ID: JR 8766
About ProPharma
For over 20 years, ProPharma has empowered biotech, medical device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies confidently. Through an advise-build-operate model, we deliver end-to-end solutions across the product lifecycle, specializing in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology. Our expertise accelerates high-profile drug and device programs while mitigating risk.
Role Overview
As a Pharmacovigilance (PV) Specialist – Submissions, you will ensure compliance with adverse event (AE) reporting requirements to health authorities, ethics committees, and safety partners using the multi-tenant Argus database. Your focus will include daily operational monitoring of AE reports, periodic reporting, submission testing, and process validation for new territories or product types.
This is an ideal opportunity for PV professionals with experience in ICSR management, periodic safety reports, and regulatory submissions who thrive in a collaborative, detail-oriented environment.
Key Responsibilities
Adverse Event Submission Compliance:
Monitor and execute scheduled expedited and non-expedited ICSRs and safety partner exchanges.
Perform monthly ICSR reconciliation with clients and safety partners.
Assist with gateway-to-gateway submission testing and compliance verification.
Create and close out submission-related deviations and CAPAs as required.
Periodic Reporting:
Generate line listings and summary tabulations from multi-tenant Argus for Periodic Safety Reports.
Assist with custom report generation and verification for periodic reporting requirements.
Support the setup and verification of PSR requirements for submission to health authorities.
Submission Projects & System Testing:
Serve as tester for PQ testing of Argus upgrades, patches, and custom projects.
Update processes and documentation for new territory or custom E2B profiles.
Perform data migration testing for Submissions in the multi-tenant Argus database.
Qualifications
Education: Post-secondary education or equivalent professional experience (Life Sciences degree preferred).
Fluent in English, with excellent verbal and written communication skills.
Proven experience in a Pharmacovigilance submissions or case processing role preferred.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel) and strong keyboarding skills.
Excellent attention to detail, organizational, and analytical skills.
Ability to adapt to fluctuating priorities and work independently or as part of a multidisciplinary team.
Why Join ProPharma
Work with a global leader in pharmacovigilance and regulatory services.
Engage in innovative safety operations projects across multiple therapeutic areas.
Flexible hybrid work environment, balancing remote work with in-office collaboration.
Be part of a diverse, inclusive, and empowering workplace.
Equal Opportunity
ProPharma is committed to diversity, equity, and inclusion. We celebrate differences and foster a safe space where every employee can thrive and contribute their authentic self.
Note: ProPharma reviews all applications personally and does not use AI screening tools. Candidates are encouraged to apply based on merit; proximity to office locations is not an advantage or disadvantage.
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