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 »
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 »
top 20 Pharmaceutical companies, to define and realize the strategic value of Regulatory Affairs, Clinical Strategy & Operations as well as Quality and Safety (eg. Pharmacovigilance).As a Senior Consultant, you will manage complex and novel consulting projects for Veeva customers in the research and development (R&D) space – managing teams more »
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 »
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 »
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 »
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 »
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 »
clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners … most high-profile drug and device programs. The Opportunity The Quality Specialist position supports the delivery of Medical Information and Pharmacovigilance services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing … supplying requested data. Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs. In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits. Supports and facilitates eQMS activities (i.e., Document Management, QA review and approvals, Change Control assessments, etc.) Other duties as needed. Maintain awareness of and more »
and reporting activities and results, updating database in accordance with the company requirements. Observation and analysis of competitors' actions and 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 the modalities (mail/web portal/fax/toll free number/post) as per the details available on https://pharmacovigilance.biocon.com/. Initial report should reach to Pharmacovigilance department within more »
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 follow up platform, Reportum, provides a centralized … tools, software, and systems to support continuous improvement initiatives (e.g., project management software, data analytics tools, process mapping software). An understanding of core pharmacovigilance processes that are supported by technology. Experience Levels : Certified Black belt in Lean Six Sigma methodologies to identify and eliminate process inefficiencies. Experience of large more »
across the product lifecycle. The candidate will also provide input into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, and pharmacovigilance processes and projects. Furthermore, the candidate will mentor and develop his or her direct reports.EXAMPLE RESPONSIBILITIES: Serves on cross-functional Global Development Teams as the … safety risksContributes to and/or oversees the preparation of aggregate safety reports, risk management plans (RMPs), and regulatory documentsCommunicates to senior management key pharmacovigilance findingsRepresents the Patient Safety at meetings with internal and external stakeholdersEnsures own work complies with established practices, policies and processes, and regulatory requirementsleads and manages … policy, or academic or subspeciality medicine. Clinical experience is preferred.Knowledge & Other Requirements Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development 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 »
life sciences industry, committed to making a positive impact on its customers, employees, and communities.The RoleThe Director role requires a deep understanding of the Pharmacovigilance function, related business processes, and the associated software applications used to collect, process, analyze and report data and manage related documents. This role is responsible … and/or services to life sciences organizationsAbility to travel for customer meetings and presentationsNice to Have5+ years of experience working within or for Pharmacovigilance organizations5+ years in management consulting rolesProven track record of thought leadership through industry presentations, publications, or other mechanismsPerks & BenefitsAllocations for continuous learning & development Health & wellness more »
