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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
