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 »
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 more »
and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients 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 »
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 »
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 »
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 »
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. Education: BS/BA required. MBA preferred. Experience Levels: Certified Change Management Professional (CCMP), Prosci methodology or equivalent Experience 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 »
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 »
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 »