- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by ... procedures through partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the business lead to ensure ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (West Palm Beach, FL)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... rare diseases and immune disorders. Summary: The Oncology Territory Manager reports to the District Manager and...team to the District ManagerNotifies the Medical Affairs & Pharmacovigilance immediately of any product complaints as per SOP… more
- Merck & Co. (North Wales, PA)
- …(SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists...labs and data transfer for biospecimen- based studiesParticipate in quality control assessments and ensure integrity of study data… more
- ThermoFisher Scientific (Waltham, MA)
- **Job Description** **Summarized Purpose:** Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region. Assess ... needed enhance and/or develop new processes while assuring consistency with global standards. **Essential Functions:** + Increase the visibility of the team/function… more
- Actalent (Morristown, NJ)
- …Ensure that all pharmacovigilance documents are prepared in time and are quality controlled. Overview of compliance in relation to the quality , completeness ... planning, preparation and submission of applicable documentation. o Ensure adequate quality of submitted documentation by performing timely review. o Ensure adequate… more
- Actalent (Parsippany Troy Hills, NJ)
- ** Pharmacovigilance Manager ** Description: + Medical review of ICSRs. + MedDRA coding + Expectedness assessment. + Causality Assessment and Company Comment. + ... pharmacovigilance documents are prepared in time and are quality controlled. + Overview of compliance in relation to...Experience Level: Expert Level About Actalent Actalent is a global leader in engineering and sciences services and talent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …has a chance to enhance their skills through ongoing development. This **Senior Manager , Global HIV Prevention Medical Affairs** role will work under the ... direction of Global HIV Medical Affairs...of GMA to local communications + Assists in the quality control and improvement of processes related to GMA projects… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will perform signal management process activities for assigned products, ... product development, registration, and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the business lead to ensure ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- BeiGene (San Mateo, CA)
- …experience, including individual study design and filing plans + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10% ... decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance ... and leadership for all aspects of quality and compliance within Global Development ...skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). Does this sound like you? Apply… more
- BeiGene (Emeryville, CA)
- …Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than ... decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal… more
- BeiGene (Springfield, IL)
- …Drug Experience Report (PADER)/Periodic Adverse Experience **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist ... Overview:** BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global , commercial-stage, research-based biotechnology company focused on molecularly targeted and… more
- International Rescue Committee (New York, NY)
- …Internal and/or external contacts: * Internal:Close working relationship with Senior Manager Quality Assurance and Pharma Technical Advisors. Regular ... Requisition ID: req51743 Job Title: Senior Procurement Manager , Procurement of Medical, WASH and NFI Commodities Sector: Supply Chain Employment Category: Regular… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description Business HR Manager , R&D PSEQ (Research & Development, Pharmacovigilance , Safety, Epidemiology, & Quality ) The HR Manager is a ... developing HR strategies, needs assessments, and resulting HR solutions for a global organization. The R&D PSEQ organization continues to evolve and focus heavily… more
- Astellas Pharma (Northbrook, IL)
- **Study Manager , Evidence Generation Operations, MA-US** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... are encouraged to apply. **Purpose and Scope:** The Senior Manager Study Operations will mainly be asked to manage...of appropriate standards and processes to ensure clinical study quality + Responsible for effective training and management of… more
- Daiichi Sankyo Inc. (West Palm Beach, FL)
- …are relevant to the marketplace, competition and the marketing team to the District Manager + Notifies the Medical Affairs & Pharmacovigilance immediately of any ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...rare diseases and immune disorders. **Summary:** The Oncology Territory Manager reports to the District Manager and… more
- Actalent (Cambridge, MA)
- Job Title: Principal Clinical Data Manager Job Description As a Principal Clinical Data Manager , your role will be to support the Directors of various groups in ... and service agreements, and to ensure deliverables are met in accordance to quality + Collaborate with clinical study teams and vendors to ensure project… more
- Merck (Rahway, NJ)
- …Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research ... **Job Description** **Position Description:** **Senior Study Manager - Epidemiology Operations** Support the Lead Epi...data transfer for biospecimen- based studies + Participate in quality control assessments and ensure integrity of study data… more
