Pharmacovigilance Associate
1 miesiąc temu
The position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.
The position will maintain and manage PSMF for clients, activities will include PSMF:
- Authoring
- Revision
- Quality check review
- Tracking
- Attend regular PSMF meetings with internal employees and Clients.
- Fulfilment of tasks assigned by the Line Manager.
- Provision of training in PSMF area.
- Revision and update of PSMF related quality documents.
Qualifications
- Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification
- Some experience/knowledge of Pharmacovigilance is required.
- Organisational skills, including attention to detail and multi tasking.
- Management skills, including time and issue management
- Excellent communication skills
Additional Information
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
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
-
Pharmacovigilance Scientists
5 miesięcy temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Medical Writer I
3 miesięcy temu
Warsaw, Polska PrimeVigilance Pełny etatJob DescriptionWe are looking for a pharmacovigilance medical writer to join our team. The Medical Writer will be responsible for medical writing including:PSURs/PBRERsPADERsACOsDSURsRMPsQC and review of all written output from the operations team as requiredSupporting the project managers to determine scheduling of the aggregate reports for which they are...
-
Veterinary Customer Response Associate with German
2 miesięcy temu
Warsaw, Polska Elanco Pełny etatAt Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...
-
Aggregate Report Analyst
4 miesięcy temu
Warsaw, Polska Pfizer Pełny etatPfizer is looking for a motivated Aggregate Report Analyst with international mindset to join the Worldwide Safety department – Site of Warsaw. Why Patients Need You Pfizer Worldwide Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment...
-
PV Associate
1 miesiąc temu
Warsaw, Polska PrimeVigilance Pełny etatJob DescriptionAssures and exerts activities leading to effective cooperation with clients in the area of ICSR ManagementContributes to achieving company´s goals and objectivesWorks under supervision of more experienced colleagueProviding support to other activities undertaken by the project team on behalf of the client and the companyPerforming activities...
-
Director Regulatory Process
6 miesięcy temu
Warsaw, Polska AstraZeneca Pełny etatAct as Regulatory Process Lead, to lead their nominated area within Regulatory Processes. Regulatory Nominated Areas Include: Clinical Trials, License Maintenance, Marketing Application and Regulatory Information a Management. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for...
-
Associate Director, Regulatory Process
6 miesięcy temu
Warsaw, Polska AstraZeneca Pełny etatWorking with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Specifically for this role the focus is intended to be CMC variation process and CMC contribution to overall Regulatory Business Processes. ...
-
Patient Safety Associate
1 miesiąc temu
Warsaw, Polska Perrigo Pełny etatAt Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the...
-
CRA II
2 tygodni temu
Warsaw, Polska Pharmiweb Pełny etatDescription Clinical Research Associate II (Poland) - Sponsor-dedicated Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the...
-
CRA II/Sr CRA
2 miesięcy temu
Warsaw, Polska Pharmiweb Pełny etatDescription Clinical Research Associate II/Sr CRA - Sponsor-dedicated Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the...