- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …in hematology, immunology, neurology, and transfusion medicine. Main Job Scope of the Sr . Clinical Study Mgr role: To manage the end to end (protocol concept ... procedures, and adhere to agreed-upon timelines and budget, while ensuring patient safety and data quality. To support and contribute to ongoing process improvement… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …requirements. Works closes with other functional groups such as medical safety evaluation team, pharmacovigilance operation, case processing, quality, and ... on real-world evidence, and creating hope for all facing illness. Manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of… more
- BeiGene (Emeryville, CA)
- …in departmental activities **Supervisory Responsibilities:** + The position has no direct reports. The Senior Manager , Safety Scientist is part of a team ... safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … safety topics for products working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , MSE will perform signal ... and for potential safety signals, and author safety aggregate reports as needed. The Manager ,... safety conclusions, and their impact for product safety profile + Mentor junior pharmacovigilance (PV)… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … safety information for studies and compound together with Pharmacovigilance . Make final decisions regarding study conduct related to scientific integrity. ... to the best of my knowledge. **Job Description** **Job Description for Senior Medical Director, Clinical Science, Marketed Products Development** As the Senior… more
- Merck (Columbus, OH)
- …and country managers to address and resolve issues, with minimal support from the Sr .COM or manager . + Ability to make decisions independently with limited ... reporting requirements internally and externally. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through...oversight from Sr .COM or manager . + Requires strong understanding… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of Safety Statistical Programming is a strategic role in the ... integrated clinical safety data for multiple compounds and indications. The Manager of Safety Statistical Programming must effectively interface with team… more
- Randstad US (Trenton, NJ)
- …and management of continuous improvements across the Regulatory and Pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness ... Substantial focus will be placed on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA, change control management activities and inspection… more
- Bristol Myers Squibb (Chicago, IL)
- …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
- Merck (Columbus, OH)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety … more
- Boehringer Ingelheim (Ridgefield, CT)
- …among team members, encourage cross-functional coordination and coordinate with the ( senior ) regulatory project manager to achieve regulatory milestones & ... apply to, or be accessible to any company recruiter worldwide. Given that the hiring manager is not based in the country you are applying for and the interview… more
- Sanofi Group (Columbus, OH)
- …distribution of key external insights diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs ... needed, on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Maintains awareness of clinical investigator… more