PV submission specialist
2 tygodni temu
- Support the client in all aspects of safety reporting for aggregate reports and related activities
- Performing submissions of aggregate reports to all concerned parties
- Performing and oversight of reporting's of Aggregate reports to Regulatory Authorities (RAs), Ethics Committees (ECs), Institutional Review Boards (IRB) and Investigators
- Tracking and archiving Aggregate reports submissions and exchanges
- Supporting the client with EudraVigilance registration and maintenance of EudraVigilance account for client
- Support in all PV operations associated with safety reporting for aggregate reports and related activities
- Quality control of daily safety reporting activities
- Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
- Participating in Audits and Inspections
- Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance safety submissions
- Demonstrated aggregate report submission experience to RAs/ECs
- eCTD sequencing experience is preffered
- Time and issue management, delegation, organization and multitasking skills with good attention to detail
- Strong interpersonal and communication skills
- Advanced English skills, both verbal and written, at least C1
Why PrimeVigilance?
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
-
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Poznań, Greater Poland Randstad Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Poznań, Greater Poland Randstad Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Poznań, Greater Poland Randstad Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Regulatory Specialist
2 tygodni temu
Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etatRegulatory Specialist supports operational activities related to maintenance of marketing authorisations (MAs) across assigned markets and/or submission types in European Partnership Markets, working in close collaboration with country leads, as well as global regulatory teams/centers and local 3 party service providers, if applicable/directed. This role...
-
Submissions Delivery Junior Specialist, Publishing
2 tygodni temu
Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etatJunior Submissions Delivery Specialist (contract till end of November 2025) In this role you will be responsible for... Delivery of submission packages to agreed schedule and technical specification, Advising and assisting authors with the preparation of submission content and use of GSK document management systems and procedures, Maintaining...
-
Senior Regulatory Specialist, CTA/IND
2 tygodni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatSite Name: Poznan Grunwaldzka, Warsaw Rzymowskiego 53Posted Date: Jun We are now looking for a SENIOR REGULATORY SPECIALIST ( CTA/ IND) to join our Polish Hub. Key Responsibilities:Coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance...
-
Compliance Reporting Specialist
2 tygodni temu
Poznań, Greater Poland zeroG - AI in Aviation Pełny etatAbout PayUPayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part ofProsusgroup, one of the largest technology investors in the world is redefining the way people buy and sell online for our merchants and millions of consumers.As a leading online...
-
Compliance Reporting Specialist
2 tygodni temu
Poznań, Greater Poland PayU Pełny etatAbout PayU PayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part of Prosus group, one of the largest technology investors in the world is redefining the way people buy and sell online for our + merchants and millions of consumers. As a leading...
-
Poznań, Greater Poland PayU Colombia Pełny etatPayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part ofProsusgroup, one of the largest technology investors in the world is redefining the way people buy and sell online for our merchants and millions of consumers. As a leading online payment...
-
PV submission specialist
2 tygodni temu
Poznań, Polska PrimeVigilance Pełny etatJob DescriptionSupport the client in all aspects of safety reporting for aggregate reports and related activitiesPerforming submissions of aggregate reports to all concerned partiesPerforming and oversight of reporting’s of Aggregate reports to Regulatory Authorities (RAs), Ethics Committees (ECs), Institutional Review Boards (IRB) and...
-
Poznań, Polska Randstad Polska Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Poznań, Polska Randstad Polska Pełny etatZacznij karierę z poczuciem celu.W GSK łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby. Naszym celem jest poprawa życia miliardów ludzi na całym świecie. Łącząc wyjątkowych ludzi w środowisku opartym o wszechstronność i integrację, możemy wywierać pozytywny wpływ w skali globalnej.ENG:Start a career with...
-
Regulatory Specialist
4 tygodni temu
Poznań, Polska 9605 GSK Services Sp z o.o. Pełny etatRegulatory Specialist supports operational activities related to maintenance of marketing authorisations (MAs) across assigned markets and/or submission types in European Partnership Markets, working in close collaboration with country leads, as well as global regulatory teams/centers and local 3 party service providers, if applicable/directed. This role...
-
Submissions Delivery Junior Specialist, Publishing
4 tygodni temu
Poznań, Polska 9605 GSK Services Sp z o.o. Pełny etatJunior Submissions Delivery Specialist (contract till end of November 2025) In this role you will be responsible for… Delivery of submission packages to agreed schedule and technical specification, Advising and assisting authors with the preparation of submission content and use of GSK document management systems and procedures, Maintaining...
-
Compliance Reporting Specialist
2 miesięcy temu
Poznań, Polska PayU Pełny etatAbout PayU PayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part of Prosus group, one of the largest technology investors in the world is redefining the way people buy and sell online for our + merchants and millions of consumers. As a leading...
-
Compliance Reporting Specialist
4 tygodni temu
Poznań, Polska PayU Pełny etatAbout PayU PayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part of Prosus group, one of the largest technology investors in the world is redefining the way people buy and sell online for our + merchants and millions of consumers. As a leading...