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 »
within the Clinical Science team. This hire will work closely with a multidisciplinary team including biostatisticians, regulatory affairs, clinical operations and data management, toxicologists, pharmacovigilance, medical affairs, market access, etc as necessary. This hire will be based in the UK, working remotely from there. As a medical expert, you will more »
medical qualification or PhD in a topic relevant to the position is beneficial. Experience working in a clinical drug development environment. Previous experience in pharmacovigilance, including advanced knowledge of PV regulation and cross-functional working. Strong knowledge of international pharmacovigilance requirements, specifically in the UK, Europe and US Salary and 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 »
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 »
be required to understand, cleanse, and present clinical safety data sets in an early stage/pre-marketing environment. Responsible for: Day-to-day pharmacovigilance oversight : Review SAEs and queries to investigators on a regular basis, support the data cleaning for safety data, and oversee signal management to identify significant … including interpretation of safety data from tables and listings. Consulting on process improvement: Support our ongoing data management transformation initiative, reviewing current processes for pharmacovigilance and safety risk management and providing input on transformation plans. Deliverables: Input to data management transformation initiative e.g. recommendations for Risk Evaluation and Mitigation Strategy more »
developing compelling technology-based business process solutions. Specific areas of capability need to be: Clinical Services Clinical Data Management BioStats & Statis Programming Safety Services Pharmacovigilance Complaints Management Regulatory Services Regulatory Operations Medical Writing Commercial Services Marketing & Sales Contract Management Solution Development Experience in developing solutions ground up, in partnership with 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 »
