- Merck & Co. (Boston, MA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance , Regulatory Compliance, Regulatory Reporting, Scientific Leadership, Scientific Publications,… more
- Daiichi Sankyo, Inc. (Boston, MA)
- …and the marketing team to the District Manager.Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting ... Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** Pharmacovigilance Operations (PV Operations), part of PSPV Strategy and Operations Office, plays ... will gain experience with global regulatory requirements surrounding good pharmacovigilance practices during audit/inspection preparation and execution **Job Requirements:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategic quality leadership by embedding global standards across Clinical, Pharmacovigilance , and Medical Quality (CPMQ), ensuring regulatory alignment and ... and drive mitigation strategies. + Organize and facilitate Clinical and Pharmacovigilance Quality council meetings, including agenda and communications. + Oversee… more
- Parexel (Boston, MA)
- …comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team ... with clients, and contribute to the continuous improvement of our pharmacovigilance processes. **Key Accountabilities:** **General** + Maintaining a good working… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Inc. is seeking a Lead Report Developer with the following duties: Deliver pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & ... Pharmacovigilance (PSPV); Identify and develop methods for statistics and...of such tools and techniques. Identify and document Global Pharmacovigilance reporting end-user system needs and requirements; Provide strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical safety ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic Area… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to ... ongoing clinical trials. + Serve as a subject matter expert in Pharmacovigilance , including operations and medical, within the assigned program. + Support… more
- Takeda Pharmaceuticals (Boston, MA)
- …compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by ... and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance -related change controls. + Provides data insights to emerging… more
