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Senior Manager Regulatory Affairs & Pharmacovigilance
not provided
DARTFORD, KENT, SOUTH EAST, UK
Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Senior Manager Regulatory Affairs & Pharmacovigilance. Job Requirements: Define, develop, and leads regional strategies to maximise regulatory and pharmacovigilance success...
PV Data Associate
GREATER LONDON, GB
...maintain data in the Pharmacovigilance Database. Monitor adverse events received via EEDR. Generate safety data for signal detection and periodic aggregate reports. Supply safety data to the regulatory department for regulatory submissions. Contribute to the continuous enhancement of the...
Pharmacovigilance Director of Projects (Europe, USA or Canada)
GUILDFORD, ENGLAND, UNITED KINGDOM
We are PrimeVigilance (part of Ergomed PLC), a specialized mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information...
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Product Surveillance Reporting Analyst
45689
MARLOW
...internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. Responsibilities: Decision maker for all reportability decisions Lead for all vigilance reporting, including local and global...
Manager, Global Aggregate Reports quality and compliance
BERKSHIRE, UNITED KINGDOM
...of new and evolving pharmacovigilance legislation within the GRIP process. Coordinates the Aggregate Reports Quality Review Board and overseeing Aggregate report KPIs across CSL business units. The authoring of high quality regulatory required aggregate reports including scientific analysis...
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PV Data Associate
GREATER LONDON
...maintain data in the Pharmacovigilance Database. /li li Monitor adverse events received via EEDR. /li li Generate safety data for signal detection and periodic aggregate reports. /li li Supply safety data to the regulatory department for regulatory submissions. /li li Contribute to the...
Pharmacovigilance Auditor
UNITED KINGDOM, UNITED KINGDOM
...audits with focus on Pharmacovigilance audits. Responsibilities include Continuous improvement of the Quality System Pharmacovigilance Audits Inspections - Regulatory Intelligence Provide advice and act as project liaison Skills Degree in natural science or equivalent number of years...
Pharmacovigilance Auditor
SLOUGH, GB
...audits with focus on Pharmacovigilance audits. Responsibilities include Continuous improvement of the Quality System Pharmacovigilance Audits Inspections - Regulatory Intelligence Provide advice and act as project liaison Skills Degree in natural science or equivalent number of years...
Countries and Regions PV Manager
CAMBRIDGE, GB
...delivery of Sobi pharmacovigilance across Sobi countries and regions. Reporting to the Head of Countries & Regions, QPPV and working closely with the Countries & Regions team , the Countries and Regions PV Manager is a key member of the GPV organisation focusing on: The Sobi GPV...
Global Quality Manager
WINDSOR, ENGLAND, UNITED KINGDOM
Excellent opportunity to join a leading pharma company as a Senior Manager - Global Quality Management. The main task is to manage and perform audits with focus on Pharmacovigilance audits. Additional tasks are to support the continuous improvement of Quality System, the inspection management, the...
Key Account & Access Manager - Diabetes
LONDON, GB
...reporting in this area. Pharmacovigilance-Reporting: The Biocon employee should follow and apply within 24h the standard Biocon PV approach if becoming aware about adverse events/side effects and/or incidents including lack of efficacy for Biocon products. Pharmacovigilance department by any of...
Senior Drug Safety Physician
UNITED KINGDOM, , UNITED KINGDOM
...to our Drug Safety and Pharmacovigilance team, supporting both medically trained and non-medical colleagues. Spearhead training and mentoring initiatives, empowering our team to excel in clinical safety data interpretation and risk management. Act as a subject matter expert in regulatory...
Senior Regulatory Affairs & PV Manager
GREATER LONDON, ENGLAND, UNITED KINGDOM
...maximize regulatory and pharmacovigilance success. knowledge of requirements of MA Transfer in EU territories, which includes requirements of notarization and translations. a team of 4 to ensure day-to-day activities are carried out in Regulatory and Pharmacovigilance. all pre-submission meetings...
Manager, Drug Safety
CAMBRIDGE, GB
...clinical safety and pharmacovigilance support to medicines across life-cycle. Reporting to the Head of Drug Safety, this role will oversee the drug safety operation and compliance activities for the development programmes and ensuring inspection readiness. Key responsibilities: Serve as the...
Continuous Improvement PMO
UNITED KINGDOM, , UNITED KINGDOM
About the company: We are Qinecsa. Trusted partners to global life science companies. We bring together and offer best-in-class pharmacovigilance technology and scientific expertise to connect life science companies to the right safety solutions. Reportum platform Our automated case intake and...
Senior Regulatory Affairs & PV Manager
GREATER LONDON, GB
...maximize regulatory and pharmacovigilance success. knowledge of requirements of MA Transfer in EU territories, which includes requirements of notarization and translations. a team of 4 to ensure day-to-day activities are carried out in Regulatory and Pharmacovigilance. all pre-submission meetings...
Automation Project Manager - Global Pharma - Perm
WATFORD, ENGLAND, UNITED KINGDOM
...Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their...
Senior Manager, GCP Quality Assurance
CAMBRIDGE, ENGLAND, UNITED KINGDOM
...Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable regulations. Identify and partner with key collaborator functions and business partners as appropriate. Assist development team business partners with development and documentation of CAPAs and...
IT Manufacturing Project Manager
WEST MIDLANDS, ENGLAND, UNITED KINGDOM
...Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their...
Clinical Trial Manager - Global Pharma - Complex Trials
UNITED KINGDOM, , UNITED KINGDOM
...Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their...
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