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 »
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 »
Surrey, 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 »
new account - delivery of product. Process product technical complaints, adverse event and medical information calls, including keeping records and completing month end reports to Pharmacovigilance and PTC management teams (when required)Training and Compliance Ensuring all SOP and training are up to date in timely manner. 100% compliant with policies 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 »
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 »
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 »
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 »
