established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP). Founded in 2007, ADAMAS has focused on more »
of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP). Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed environment. Demonstrates good analytical more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
more. My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform 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' experience Experience in Pharmacovigilance auditing KEY RESPONSIBILITIES & DECISIONS 1. Pharmacovigilance Audits · Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities · Manage audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise … GxP compliance · Act as quality liaison for assigned projects QUALIFICATIONS/EXPERIENCE · Degree in natural science or equivalent number of years’ experience · Experience in Pharmacovigilance auditing (Qualification as an auditor preferred) · Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilancemore »
SPC, PIL, cartons and labelling) and associated mock-ups. Prepare Artwork Submissions that include P1 Applications, Article 61 (3) Notifications Liaise with the External Pharmacovigilance consultants for submission of Safety variations and PSUSA Variations. Working with specialist computer software and resources; (Eg: ectd). Experience in uploading the product information more »
Safety Medical Director, Oncology, UK - Remote Live What you will do In this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety more »
product(s). Requirements and Skills: Bachelor’s or master’s degree in relevant field (e.g., Biology, Chemistry, MBA) or equivalent work experience supporting pharmacovigilance activities Proven experience as an IT Product Manager, preferably in an R&D or technology-driven environment or pharmaceutical industry Strong understanding of software development more »
at Cpl Life Sciences (previously Only Medics/Clinical Professionals) is a specialist division that focuses exclusively on recruitment of Medical Affairs, Clinical Development & Pharmacovigilance for pharmaceutical companies, biotechnology companies, Clinical Research Organisations (CROs) and Regulatory Authorities. more »
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
actions and provide the Third Party QA Manager with a conclusive summary as base for his final review. To overview and request timely annual Pharmacovigilance statements for PQRs. To support QA management in any quality related matter. Minimum Qualification (education, experience and/or training, required certifications): Scientific Degree or more »
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
Hertfordshire, England, United Kingdom Hybrid / WFH Options
Planet Pharma
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
Andover, England, United Kingdom Hybrid / WFH Options
Planet Pharma
have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: 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 more »
responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with 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 submissions • Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate • Ensures that relevant stakeholders have visibility to the reporting and where they are in the process • Manages regular reporting needs and more »
care and need your expertise to make it happen. 👩💼 QPPV Office & Alliance Manager (f/m/d) 🔍 What You'll Do: Lead global Pharmacovigilance system with finesse, ensuring compliance and efficiency. Dive deep into international agreements, safeguarding Pharmacovigilance standards. Craft and negotiate Drug Safety Agreements, driving global consistency. Seamlessly more »