- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... Clinical Trial Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Pharmacovigilance Scientist, Senior Manager ** **Live** **What you will do** Let's ... provides oversight to staff with regards to safety in clinical trials Review and provide input and support on...of role and responsibility + Processes and regulations for pharmacovigilance and risk management + Drug development and lifecycle… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Sr . Manager , Pharmacovigilance PV Operations, US - Remote** **Live** **What you ... to development and delivery of compliant eCRF/CRFs that facilitate accurate and complete clinical trial SAE data and post market AE data are collected in line… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Senior Manager , Pharmacovigilance (PV) Business Partner Relations in ... Lexington, MA with the following requirements: Bachelor's degree in Clinical , Regulatory Affairs, Pharmacy, or related field or foreign academic equivalent plus 5… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring requirements. Works closes with other functional groups such as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** **Job Description for Senior Medical Director, Clinical Science, Marketed Products Development** As the ... Director Marketed Products (SMDMP) you will report to the Head of Global Clinical Science, Marketed Products Group and are accountable for Medical Sponsor and … more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The role of Senior Clinical Program Leader (CPL) - Retinal health, assumes full medico-scientific and strategic leadership of clinical ... integrates as chairperson the output of cross-functional evidence team ( Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory,… more
- BeiGene (Emeryville, CA)
- …departmental activities **Supervisory Responsibilities:** + The position has no direct reports. The Senior Manager , Safety Scientist is part of a team that ... + Assist with integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in… more
- Merck (Columbus, OH)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study...allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in… more
- Merck (North Wales, PA)
- **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through ... Trial Team (CTT) + May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study deliverables. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... on real-world evidence, and creating hope for all facing illness. The Senior Managerwill support signal detection activities and medical analyses to support… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... Development role. Strong Expertise with transferable skills related to Good Clinical Practice(GCP), and/or Good Pharmacovigilance Practice (GVP). Does this… more
- Sanofi Group (Cambridge, MA)
- …treatment to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty ... therapies and when they are not eligible to participate in a clinical trial. Cross-GBU Pre-Registration Import License (PRIL) is designed to oversee temporary… more
- Merck (Columbus, OH)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential ... Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of… more
- AbbVie (North Chicago, IL)
- …development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions. + Ensures adherence ... disease area and platform level. + Acts as a senior -level liaison for opinion leader interactions related to the...to Good Clinical Practices, pharmacovigilance standards, standard operating procedures… more
- Editas Medicine (Cambridge, MA)
- …and pharmacovigilance , and is responsible for protocol development and clinical sections of regulatory documents (e,g. IND submission, briefing documents, study ... The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves'...clinical programs. + Ability to work with the Senior Executive Team and other external audiences such KOLs,… more
- Randstad US (Cambridge, MA)
- senior safety associate iii. + cambridge , massachusetts + posted 10 days ago **job details** summary + $50.72 - $57.58 per hour + contract + bachelor degree + ... 57.58 per hour work hours: 9 to 5 education: Bachelors responsibilities: The Senior Safety Associate III will be responsible for supporting Global Case Management… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of Safety Statistical Programming is a strategic role in the emerging ... the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications. The Manager… more
- Bristol Myers Squibb (Minneapolis, MN)
- …and payers. The RD position is also responsible for working closely with senior management to create and execute medical initiatives at a national level. This ... customer-focus and BMS enterprise view + Establish a trusted partner relationship with senior leaders at the account + Creates a collaborative exchange with account… more
- Pfizer (Tampa, FL)
- **Role Summary** The Audit Manager , Research, Development and Supply will be part of Pfizer Corporate Audit's internal team that provides "third line of defense" ... Chain to plan and execute best in class audit assurance. The Audit Manager is responsible for identifying risks in specific business areas and conducting independent… more