- Takeda Pharmaceuticals (Boston, MA)
- …adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance (PV) regulated environment. + Supports ... of 5 years prior experience in pharmaceutical industry in a drug safety/ pharmacovigilance global setting + Experience in developing procedural documents and training… more
- Sumitomo Pharma (Raleigh, NC)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director.** The Associate Medical Director will provide hands-on ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance ... Grifols pharmaceutical products. + Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with… more
- Amgen (Washington, DC)
- …and implements retrospective database studies in support of safety and pharmacovigilance . + Provides epidemiological input to worldwide regulatory submissions such ... scientific experience Or Bachelor's Degree and 4 years of scientific experience Or Associate 's degree and 8 years of scientific experience Or High school diploma /… more
- Sumitomo Pharma (Bismarck, ND)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM...(CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will… more
- United Therapeutics (Phoenix, AZ)
- …are passionate about PV and enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and oversight ... role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …candidates with a less traditional background. **Job Description** We are seeking an Associate for our North America Medical Affairs team. This is a critical role ... within our Pharmacovigilance and Medical Affairs team. The incumbent will be...NJ (Hybrid) and will report directly to the Head Pharmacovigilance and Medical Affairs - North America **Responsibilities:** *… more
- Takeda Pharmaceuticals (Boston, MA)
- …and empower you to shine? Join us as a PV Risk Management Scientist/ Associate Director. At Takeda, we are transforming the pharmaceutical industry through our ... encourage innovation, and strive for excellence in everything we do. As an Associate Director/ PV Risk Management Scientist, being part of our Risk Management and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …barriers, together. Opportunity Overview Rhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently develop as ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director, Global Patient Safety Medical Science reports to Head of GPS Medical ... + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Senior Associate , R&D Compliance** **What you will do** Let's do this! Let's change the ... Qualifications:** + High school/GED + 4 years quality compliance work experience OR Associate 's + 2 years quality compliance work experience OR Bachelor's + 6 months… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality of laboratory data… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director, Data Management Processes, Training and Inspection Readiness, is ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality of deliverables to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the ... Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation… more
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation… more
- AbbVie (North Chicago, IL)
- …to support potential product related issues *Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and Clinical ... device/ combination product vigilance (safety signal detection, data mining techniques, pharmacovigilance / device vigilance databases, etc.) + Track record of… more
- Amgen (Washington, DC)
- …experience in a hospital, university or clinical research unit setting **Or** Associate 's degree (ADN) and 10 years of Safety/ Pharmacovigilance or Clinical ... degree (PhD or DNP) OR PharmD OR MD and 2 years of Safety/ Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. The purpose of the Associate /Senior Associate /Principal Associate - MQO is to support the development ... + Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. + Serve as an IT systems business quality… more
- University of Miami (Miami, FL)
- …of Executive Dean of Research is currently seeking a Clinical Research Safety Associate to work in Miami. The Clinical Research Safety Associate (CRSA) ... The CRSA works closely with clinical research, regulatory affairs, and pharmacovigilance teams to maintain the safety and compliance of investigational products.… more