Senior Pharmacovigilance
1 month ago
When our values align, there's no limit to what we can achieve.
Due to an expanding portfolio, we have an exciting opportunity for a highly skilled and experienced Senior Pharmacovigilance (PV) Compliance Manager, QA to join our team in the Czech Republic or other selected Eastern Europe countries.
Candidates must have a strong knowledge and experience of audits of PV systems and able to document this in their CV and demonstrate it in an interview.
As a Senior PV Compliance Manager, you will play a crucial role in ensuring compliance of Parexel with Pharmacovigilance regulations, standards, and best practices. You will conduct audits of internal PV systems, processes, and activities to identify potential risks, gaps, and areas for improvement.
Main responsibilities are:
Conduct comprehensive audits of Pharmacovigilance systems, processes, and activities to evaluate compliance with applicable regulations, guidelines, and standard operating procedures. Assess the documentation, databases, and records related to AE reporting, signal detection, risk management, and QMS. Evaluate the effectiveness of Pharmacovigilance systems in detecting, evaluating, and managing safety signals and ensuring appropriate risk minimization strategies are in place Support and oversee the 3 year strategic PV audit plan of Parexel Collaborate with cross-functional teams, such as GSS, Quality and Clinical Operations, to address audit findings and implement corrective actions. Stay updated with the latest Pharmacovigilance regulations, guidelines, and industry best practices, and apply this knowledge during audits to ensure compliance and continuous improvement. Provide guidance and mentorship to more junior PV auditors, sharing expertise and knowledge to facilitate their professional growthKnowledge and Experience :
Extensive experience in safety/pharmacovigilance, auditing, including sound experience of applicable GxP auditing, regulatory affairs, quality assurance. Significant industry experience in conduct audits of internal PV systems, processes, and activities to identify potential risks, gaps, and areas for improvement Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research. English proficiency (written and oral)Skills:
Emerging ability to lead without explicit authority Self-management: independent, takes initiative, proactive and organized Focused on quality results - attention to detail and First Time Quality Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned) Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge Cultural awareness with the ability to think and work, globally Ability to travel as needed for the positionEducation:
Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred-
Senior Director, Pharmacovigilance Intelligence
2 weeks ago
Uxbridge, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Director, Pharmacovigilance Intelligence
1 month ago
Uxbridge, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Director, Pharmacovigilance Intelligence
2 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Uxbridge, United Kingdom Pharmiweb Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Director, Pharmacovigilance Intelligence
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Director, Pharmacovigilance Intelligence
2 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Director, Pharmacovigilance Intelligence
1 month ago
Uxbridge, London , Uxbridge, London, London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Senior Director, Pharmacovigilance Intelligence
3 weeks ago
Uxbridge, London , Uxbridge, London, London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Senior Director, Pharmacovigilance Intelligence
1 month ago
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Senior Director, Pharmacovigilance Intelligence
4 weeks ago
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Senior Director, Pharmacovigilance Intelligence
3 weeks ago
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Senior Director, Pharmacovigilance Intelligence
3 weeks ago
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance...
-
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Uxbridge, Greater London, United Kingdom Regeneron Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV)...
-
Senior Digital Communications Manager
2 weeks ago
Uxbridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Senior Digital Communications Manager to join a global pharmaceutical company, based in Uxbridge, London on a contract basis for 12 months. This is full time position (35 hours per week) and you will be required on site 50%of the week **Salary**: £30.00 per hour PAYE **Company**: Our client is the global leader in enabling...
-
HR Project Manager
2 months ago
Uxbridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a HR Project Manager to join a global pharmaceutical company, based in the Uxbridge on a contract basis for 6 months. **Salary**: £30.00 per hour PAYE - this role is inside IR35 **Company**: Our client is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full...
-
Compliance & Contracts Senior Manager
2 weeks ago
Uxbridge, United Kingdom Almirall Full timeAbout Almirall We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are dedicated to providing the tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and market our own medicines as well as a portfolio of licensed medicines designed to respond...
-
Senior Monitoring Manager
4 weeks ago
Uxbridge, Greater London, United Kingdom Regeneron Full timeThis position is to support the Global Patient Safety (GPS) department in business support of safety systems utilized for pharmacovigilance. This includes overseeing daily activities such as generating searches and output in support of departmental data requests, internal audits, and health authority inspections. impact assessments and testing reports before...
