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. 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:
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.
Execution of monthly ICSR reconciliation reports with PV clients and their safety partners.
Assists in testing gateway-to-gateway submissions to health authorities and ICSR exchange with their safety partners.
Assists with creation and closeout of all submissions-related deviations and associated CAPAs.
Periodic Reports:
Generates multi-tenant Argus-based line listings and summary tabulations for Periodic Safety Reports.
Assists with the generation and verification of custom reports for periodic reporting.
Assists in the setup and verification of Periodic Safety Report requirements to health authorities.
Assists the pharmacovigilance management team in coordinating, developing, and maintaining all aspects of ProPharma Group’s pharmacovigilance reporting services.
Submission projects:
Fulfills the tester role in performance qualification (PQ) testing for multi-tenant Argus upgrades, patches, and custom projects.
Executes process and documentation updates associated with new territory specific E2B profiles and custom E2B profiles.
Fulfills the tester role for Submissions-based PQ testing for data migration imports involving the multi-tenant Argus database.
Experience required
Post-secondary education or equivalent professional work experience (life science degree preferred)
Fluent in English
Proven experience in a similar role would be highly preferred
Proficient computer knowledge, specifically Microsoft Office Suite (Outlook, Word, Excel) and computer keyboarding skills.
Excellent attention to detail.
Strong verbal, written and interpersonal communication skills.
Flexibility to adapt and meet fluctuating business priorities.
Ability to work independently and collaboratively in a multidisciplinary team.
#LI-DNI
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
