- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... and procedures, as applicable.On a daily basis provide total oversight on the processes relating to the conduct of...as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the activities of Rhythm's safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties + Reviews adverse event ... PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our medications.… more
- Lilly (Indianapolis, IN)
- …influence quality related policies and regulatory requirements related to **2) Quality Metrics and Oversight ** + Establishes key performance measures and ... better for people around the world. **Purpose:** The purpose of the Senior Director - Benefit-Risk Management Group Leader is to lead the development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... in the biopharma industry, including significant relevant experience working in quality , compliance, pharmacovigilance , or a related field. Extensive experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated ... in the business units and affiliates. + Ensure that the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities… more
- Actalent (Frederick, MD)
- Description Quality Assurance Director with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical ... The ideal candidate will be a highly motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee… more
- Ascendis Pharma (Palo Alto, CA)
- …the Director , ICSR Management Team is responsible for the oversight of all ICSR Management activities including ICSR processing workflow management, submission ... for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head,...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Ascendis Pharma (Palo Alto, CA)
- …the guidance of Head of PV Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source data quality ... a dynamic workplace for employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the Director , Head, PV Vendor… more
- Amgen (Thousand Oaks, CA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director Global Safety** **What you will do and what we expect of you** Let's ... Direct the planning, preparation, writing and review of aggregate reports; Provide oversight to staff with regards to safety in clinical trials including review… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Responsibilities** The Senior Director , Global Process Owner for Quality Risk Management, as a leader ... Systems team, will establish and maintain the global quality system for Quality Risk Management. They will provide strategic oversight and expertise for the… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... leading a global team focused on R&D Quality . This global role includes direct reports in the...inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + **Audit Management:** Oversee the planning,… more
- AbbVie (South San Francisco, CA)
- …serve a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of statisticians in oncology. This role will be ... specifications to address both pre-planned safety analyses and ad hoc requests. + Oversight to ensure the delivery of high- quality outputs according to… more
- Takeda Pharmaceuticals (Boston, MA)
- …areas and stakeholder groups on the medical coding strategy, implementation, and quality oversight .** **Provide coding expertise and capability in support of ... and empower you to shine? Join us as a Director , Clinical Data Management Medical Coding based remotely reporting...optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality . + In… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. The purpose of the Associate Director - Safety Data Scientist is to manage and analyze complex Global Patient Safety ... assess business issues, and drive analytic solutions. The Safety Data Scientist Associate Director / Director will work with stakeholders to analyze workflows… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ready ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is...and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may… more
- ICON Clinical Research (Blue Bell, PA)
- Medical Director Pulmonology (Biotech)- Blue Bell, PA- REMOTE ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to ... of drugs and devices that save lives and improve quality of life. Our people are our greatest strength,...do well. We are currently looking for a **Medical Director ** specializing in **Pulmonology** to join our global Biotech… more
- Sanofi Group (Cambridge, MA)
- …stakeholders. + Collaborate with Global Project Heads, Clinical Research Director , Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...and clinical study reports. + Ensure scientific relevance and quality of clinical data throughout study execution. + Support… more
- AbbVie (Irvine, CA)
- …we're committed to providing the most comprehensive science-based product offerings available. The Director I will provide direction and oversight to the design, ... and lead cross-functional teams to generate, deliver and interpret high quality research and clinical data supporting aesthetic indications and overall asset… more
- Taiho Oncology (Pleasanton, CA)
- …of cross-functional areas (eg, clinical operations, biostatistics, data management, biomarker, pharmacovigilance , quality , etc.) + Knowledge in authoring key ... direct responsibility for leading global development program(s), including strategy, design, oversight , and analysis of Phase 1-4 oncology clinical trials. This… more
- Ascendis Pharma (Palo Alto, CA)
- …by PV Vendor and provide feedback and guidance as applicable. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality ... + Provides input to assigned vendors to improve the quality of Adverse Event intake. + Performs late case...Preventative action (CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely… more
