Pharmacovigilance Specialist – Submissions
Job ID: JR 8766
Location: India
Employment Type: Full-time
Industry: Pharmacovigilance | Drug Safety | Regulatory Compliance
About ProPharma
For over two decades, ProPharma has been a trusted global partner in advancing patient health by supporting biotech, medical device, and pharmaceutical organizations across the full product lifecycle. Operating through an advise–build–operate model, ProPharma delivers integrated solutions spanning regulatory sciences, pharmacovigilance, clinical research, quality & compliance, medical information, and R&D technology. The company’s deep domain expertise helps clients de-risk development programs and accelerate the delivery of innovative therapies worldwide.
Job Overview
ProPharma is seeking a Pharmacovigilance Specialist – Submissions to support global adverse event reporting and regulatory submissions activities. This role plays a critical part in ensuring compliance with global health authority requirements by managing adverse event submissions and safety data exchanges within a multi-tenant Argus Safety database. The position requires strong operational execution, attention to detail, and collaboration with internal teams and external safety partners.
Key Responsibilities
Adverse Event Submissions & Safety Data Exchange
Ensure compliance with global pharmacovigilance reporting requirements, including expedited and non-expedited Individual Case Safety Reports (ICSRs).
Perform daily monitoring and tracking of adverse event submissions and safety data exchanges.
Execute monthly ICSR reconciliation activities with pharmacovigilance clients and safety partners.
Support gateway-to-gateway submission testing with global health authorities and safety partners.
Assist in the creation, investigation, and closure of submissions-related deviations and CAPAs.
Periodic Safety Reports
Generate Argus-based line listings and summary tabulations for periodic safety reports.
Support preparation, verification, and customization of periodic reporting outputs.
Assist in setup, maintenance, and validation of periodic reporting requirements for global health authorities.
Submissions Projects & System Testing
Participate as a tester in Performance Qualification (PQ) testing for Argus Safety upgrades, patches, and custom enhancements.
Execute documentation and process updates for new territory-specific and custom E2B profiles.
Support PQ testing for submissions-related data migrations within the Argus environment.
Collaborate with pharmacovigilance leadership to enhance and maintain submissions and reporting services.
Experience & Qualifications
Education:
Post-secondary education required; a degree in Life Sciences, Pharmacy, or a related discipline is preferred.
Experience Required:
Minimum 1–3 years of experience in pharmacovigilance submissions, drug safety operations, or a closely related role (experience in a global environment preferred).
Hands-on experience with Argus Safety and adverse event submission workflows is highly desirable.
Skills & Competencies:
Strong understanding of global pharmacovigilance regulatory reporting requirements.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel).
Excellent attention to detail with strong documentation and compliance focus.
Effective verbal, written, and interpersonal communication skills in English.
Ability to manage multiple priorities, work independently, and collaborate within cross-functional teams.
Adaptability to changing business needs and regulatory requirements.
Diversity, Equity & Inclusion
ProPharma is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and supportive workplace. Employees are encouraged to bring their authentic selves to work and contribute through innovation, collaboration, and continuous learning.
Work Model
While ProPharma supports remote working, candidates located within reasonable commuting distance of a company office may be encouraged to work in a hybrid model, subject to role requirements and manager agreement.
Important Notice
ProPharma Group does not accept unsolicited resumes from recruitment agencies or third parties. All applications are reviewed directly by the ProPharma recruitment team, and every applicant will receive a response regarding their application status.
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