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 »
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 »
East Kilbride, South Lanarkshire Hybrid / WFH Options
Real Staffing
ideally medical device legislation (not a deal breaker) Regulatory exposure to environments in local and international territories Working in or with manufacturing, quality assurance, pharmacovigilance, marketing and commercial Interfacing with Competent Authorities Ability to travel as required Qualifications: Either Degree in Life Science or track record in a similar position 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 »
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 »
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 »
backgrounds within research, healthcare, industry and the academic sphere. Job Description This position is a key role in supporting the effective 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 … the GPV organisation focusing on: The Sobi GPV outreach strategy to Sobi country and regional PV developing, supporting, and driving excellence in post-approval pharmacovigilance activities related to Sobi and Sobi’s partner products, to ensure local compliance with Sobi/Partner PV system requirements. Provide input to Sobi’s … PV system, for new products and new markets Interaction with vendors contracted to perform local and regional PV activities in order to drive local Pharmacovigilance (PV) performance, deliver compliant, effective, efficient and business appropriate standards and processes, and supporting oversight and audit/inspection readiness. Facilitation and communication of PV 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 »
Farnborough Business Park, 1 Pinehurst Road, Farnborough, Hampshire, England
SYNEOS HEALTH UK LIMITED
This is an office-based role, where you will support a mix of departments, such as TMF; Clinical Operations; Study Start Up; Stats & Programming; Pharmacovigilance; Reg Affairs; Proposals. Role Supporting assigned departments with daily business operations involved in clinical trials as determined by business needs Performing your daily activities in … apprentice and may include the following functional areas: TMF Operations; Site & Patient Access; Proposals; Clinical Operations; Clinical Monitoring; Study Start Up; Stats and Programming; Pharmacovigilance Training Qualification: BSc Applied Bioscience One day per week remote learning Potentially suitable roles at the end of the apprenticeship scheme might be: Clinical Research more »
