Pharmacovigilance Specialist – Submissions
Company: ProPharma
Location: India
Job Type: Full-Time
Department: Pharmacovigilance / Drug Safety Operations
Work Model: Remote / Hybrid
About ProPharma
For more than 20 years, ProPharma has been a global leader in delivering expert solutions across pharmacovigilance, regulatory sciences, clinical research, medical information, quality & compliance, and R&D technology services. The company partners with biotechnology, pharmaceutical, and medical device organizations worldwide to accelerate drug development, ensure regulatory compliance, and support patient safety throughout the product lifecycle.
With deep expertise in drug safety and regulatory operations, ProPharma provides innovative, scalable, and customized healthcare consulting solutions that empower organizations to bring life-changing therapies to market safely and efficiently.
Job Title: Pharmacovigilance Specialist – Submissions
Job Overview
ProPharma is hiring a Pharmacovigilance Specialist – Submissions to support global pharmacovigilance operations and regulatory safety reporting activities. This role is responsible for ensuring compliance with adverse event submission requirements to health authorities, ethics committees, institutional review boards, and safety partners using the Argus Safety Database.
The ideal candidate will have strong expertise in Individual Case Safety Report (ICSR) submissions, periodic safety reporting, E2B compliance processes, and pharmacovigilance operational workflows. Candidates with experience in Argus Safety, regulatory submissions, and PV compliance activities will be highly preferred.
This opportunity is ideal for life science professionals looking to build or advance a career in global pharmacovigilance operations, drug safety submissions, and regulatory compliance.
Key Responsibilities
Adverse Event Submission & Safety Exchange Compliance
Monitor daily expedited and non-expedited ICSR submissions and safety exchanges.
Ensure compliance with global pharmacovigilance reporting requirements and submission timelines.
Track adverse event submissions through the multi-tenant Argus Safety Database.
Support gateway-to-gateway testing for health authority submissions and safety partner exchanges.
Perform monthly ICSR reconciliation activities with clients and safety partners.
Assist in identifying, documenting, and resolving submissions-related deviations and CAPAs.
Maintain accurate documentation related to pharmacovigilance submission processes.
Periodic Safety Reporting Activities
Generate Argus-based line listings and summary tabulations for periodic safety reports.
Assist in preparing and validating custom reports for aggregate reporting activities.
Support setup, maintenance, and verification of periodic reporting requirements for global health authorities.
Collaborate with pharmacovigilance management teams on reporting operations and compliance initiatives.
Submission Projects & System Support
Participate in Performance Qualification (PQ) testing for Argus upgrades, patches, and system enhancements.
Execute testing activities related to new territory-specific E2B profiles and customized E2B configurations.
Support submissions-related data migration testing and validation activities.
Contribute to process improvement initiatives within global pharmacovigilance operations.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or a related healthcare discipline preferred.
Strong understanding of pharmacovigilance principles and regulatory reporting requirements.
Experience with Argus Safety Database or other pharmacovigilance safety systems is preferred.
Good knowledge of ICSR processing, E2B submissions, and aggregate safety reporting.
Proficiency in Microsoft Office Suite including Excel, Word, and Outlook.
Excellent verbal and written communication skills in English.
Strong analytical skills and attention to detail.
Ability to work independently as well as collaboratively within cross-functional teams.
Flexible mindset with the ability to manage changing business priorities.
Experience Required
Freshers: Eligible to apply if they possess relevant pharmacovigilance training, internships, or academic exposure to drug safety and regulatory submissions.
Experienced Candidates: 1–4 years of experience in pharmacovigilance submissions, ICSR compliance, Argus Safety, or regulatory operations will be highly preferred.
Preferred Skills
Knowledge of global pharmacovigilance regulations and submission standards.
Experience in E2B(R3) compliance and health authority reporting workflows.
Familiarity with CAPA management and deviation handling.
Exposure to periodic safety reports such as PSUR, PBRER, DSUR, or aggregate reporting processes.
Understanding of pharmacovigilance quality and compliance procedures.
Why Join ProPharma?
Opportunity to work with a globally recognized pharmacovigilance and regulatory consulting organization.
Exposure to international drug safety operations and regulatory submission processes.
Collaborative and inclusive work culture focused on innovation and professional growth.
Career development opportunities within pharmacovigilance, regulatory affairs, and clinical research domains.
Work alongside experienced global healthcare and life science professionals.
Equal Opportunity Statement
ProPharma is committed to creating a diverse, equitable, and inclusive workplace where employees are empowered to grow, innovate, and succeed. The company values collaboration, authenticity, and equal opportunity for all professionals.
All applications are reviewed directly by the recruitment team without AI-based screening processes.
Important Note
ProPharma does not accept unsolicited resumes from third-party recruiters or agencies for this role.
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