Pharmacovigilance Specialist, Submissions
Location: Remote
About ProPharma
For the past 20 years, ProPharma has been dedicated to improving patient health and wellness by providing expert guidance to biotech, medical device, and pharmaceutical organizations. As the world's largest Research Consulting Organization (RCO), we partner with clients through an advise-build-operate model across the entire product lifecycle. Our expertise spans regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology, offering fully customizable consulting solutions to accelerate drug and device programs.
Position Overview
The Pharmacovigilance (PV) Specialist, Submissions is responsible for ensuring adherence to operational processes while managing adverse event submissions using the multi-tenant Argus and ARISg databases. This role focuses on daily tracking of adverse event reports, maintaining compliance with health authorities, ethics committees, and safety partners, and supporting submission processes for new territories and product types.
Key Responsibilities
Adverse Event Submission and Compliance:
Follow ProPharma processes for pharmacovigilance regulatory reporting, including monitoring expedited and non-expedited ICSR submissions.
Execute monthly ICSR reconciliation reports with clients and safety partners.
Assist in testing submissions to health authorities and exchanges with safety partners.
Manage submissions-related deviations and CAPAs.
Periodic Reports:
Generate Argus-based line listings and summary tabulations for Periodic Safety Reports.
Assist in the generation and verification of custom reports for periodic reporting.
Support the pharmacovigilance management team in maintaining reporting services.
Submission Projects:
Participate in performance qualification testing for Argus upgrades and custom projects.
Update documentation for new territory-specific E2B profiles.
Test data migration imports involving the multi-tenant Argus database.
Experience Required
Post-secondary education or equivalent professional experience (life science degree preferred).
Fluent in English.
Proven experience in a similar role is highly preferred.
Proficient in Microsoft Office Suite (Outlook, Word, Excel) and strong keyboarding skills.
Excellent attention to detail and strong communication skills.
Flexibility to adapt to changing business priorities.
Ability to work independently and collaboratively in a multidisciplinary team.
Commitment to Diversity
At ProPharma, we celebrate our differences and strive to create a workplace where everyone can be their authentic selves. We are committed to diversity, equity, and inclusion, providing a safe space where all employees feel empowered to succeed.
Gujarat :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Buenos Aires |Republic of Egypt :
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Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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