For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Role
The Pharmacovigilance (PV) Specialist, Submissions position is responsible for adherence to daily operational processes while working within the multi-tenant Argus database to ensure adverse event submission compliance with health authorities, ethics committees, institutional review boards, and safety partners. The Specialist’s primary foci are on daily operational system tracking of adverse event reports and periodic reports, maintenance of adverse event submission and exchange compliance, testing for health authority submission, and process testing for submitting adverse event cases to new territories and/or for new product types.
Adverse event submission and safety partner exchange compliance:
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Adheres to ProPharma processes and instructions associated with pharmacovigilance regulatory reporting, including daily monitoring of scheduled expedited and non-expedited individual case safety report (ICSR) submissions and exchanges.
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Execution of monthly ICSR reconciliation reports with PV clients and their safety partners.
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Assists in testing gateway-to-gateway submissions to health authorities and ICSR exchange with their safety partners.
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Assists with creation and closeout of all submissions-related deviations and associated CAPAs.
Periodic Reports:
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Generates multi-tenant Argus-based line listings and summary tabulations for Periodic Safety Reports.
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Assists with the generation and verification of custom reports for periodic reporting.
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Assists in the setup and verification of Periodic Safety Report requirements to health authorities.
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Assists the pharmacovigilance management team in coordinating, developing, and maintaining all aspects of ProPharma Group’s pharmacovigilance reporting services.
Submission projects:
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Fulfills the tester role in performance qualification (PQ) testing for multi-tenant Argus upgrades, patches, and custom projects.
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Executes process and documentation updates associated with new territory specific E2B profiles and custom E2B profiles.
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Fulfills the tester role for Submissions-based PQ testing for data migration imports involving the multi-tenant Argus database.
Experience required
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Post-secondary education or equivalent professional work experience (life science degree preferred)
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Fluent in English
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Proven experience in a similar role would be highly preferred
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Proficient computer knowledge, specifically Microsoft Office Suite (Outlook, Word, Excel) and computer keyboarding skills.
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Excellent attention to detail.
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Strong verbal, written and interpersonal communication skills.
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Flexibility to adapt and meet fluctuating business priorities.
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Ability to work independently and collaboratively in a multidisciplinary team.
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***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Top Skills
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
