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 »
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 »
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 »
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 »
