- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Manager PS Case Management is responsible for the management of receipt, documentation, triage and ... within the pharmaceutical or healthcare industry. A minimum of 2 year's of pharmacovigilance case processing experience is preferred Experience in patient safety or … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Functions Administration: Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing ... ensure compliance with SDEA requirements Supports development and maintenance of Pharmacovigilance System Master File (PSMF). Ensures accuracy and completeness of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance Must have proficiency in ICH GCP Guidelines, US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Manager - Technical Complaints Call Center Oversight is responsible for overseeing the initial ... timely manner Serve as Technical Complaint Processing Team's safety system manager Oversight of quality management: Facilitates and/or participates in regularly… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance ... function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous… more
- Daiichi Sankyo, Inc. (Louisville, KY)
- …to the marketplace, competition and the marketing team to the District Manager .Notifies the Medical Affairs Pharmacovigilance immediately of any product ... centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory … more
- Insmed Incorporated (NJ)
- …organizational priorities and compliance requirements.Partner with the Patient Services Training Manager to strengthen Case Manager and Patient Support ... reporting, ensuring timely and accurate communication.Collaborate with Legal, Compliance, Pharmacovigilance , and Quality to maintain adherence to all relevant laws,… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving ... oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/ Pharmacovigilance , Clinical, CMC, and Regulatory Technology teams. While Regulatory… more
- BeOne Medicines (San Mateo, CA)
- …programs (hereinafter collectively referred as "Programs" below) to ensure all pharmacovigilance activities required in such Programs are performed in an efficient, ... and compliant manner. The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and externally ensure… more
- BeOne Medicines (Emeryville, CA)
- …integrated Benefit/Risk assessments. **Promote and Advance the Field of Pharmacovigilance ** + Responsible for effective execution, communication and influence with ... organizational effectiveness and productivity. + Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.… more
- Parexel (Des Moines, IA)
- **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a remote role !_** **Position Purpose:** The Clinical Quality ... Operations Manager (CQOM), in collaboration with the Clinical Quality Operations...(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Senior Manager , Regulatory Science? The job is in our King of Prussia, PA office. This ... strategies align with current and emerging requirements. - **Safety and Pharmacovigilance Intelligence** Monitor, track and analyze global PV regulations, safety… more
- Parexel (Baton Rouge, LA)
- …of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support - Provide medical input into PV workflows and projects and ... assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction Business Development… more
- BeOne Medicines (Emeryville, CA)
- …development intelligence, US Marketing, Global Marketing, US Sales, safety/ pharmacovigilance , molecular diagnostics, new markets, and translational research. The ... BeOne Core Values Essential Functions: + Oversee the daily 1st line manager activities of the Field Medical Team while providing executive-level support for… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- Associate Manager , Pharmacovigilance Department: Pharmacovigilance Location: Mahwah, NJ START YOUR APPLICATION ... About the Job This role reports to the Regional Pharmacovigilance Head - North America. The successful individual will...assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, accurate and timely… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure ... high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines....IT-related PV projects. + Drive Innovation through AI in Pharmacovigilance : Stay at the forefront of artificial intelligence advancements… more
- Cognizant (Abbott Park, IL)
- Sr. Manager - Pharmacovigilance (REMOTE) Provide strategic leadership in the maintenance and oversight of safety systems, including system upgrades, migrations, ... of new training programs for Empirica Systems ▪ Participate in pharmacovigilance (PV) activities, including regulatory responses, Business and System configuration… 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 ... **How You Will Contribute:** Duties will include the following, under the manager 's supervision + Support the collection and processing of safety information +… more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. Global Safety Senior Manager , Rare Disease **What you will do** Let's do this. Let's change the ... + Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance ...for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state… more
- Sumitomo Pharma (Providence, RI)
- …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
