- Takeda Pharmaceuticals (Boston, MA)
- …adequate training support to all functional areas within PSPV in a Pharmacovigilance (PV) regulated environment. + Supports the development and delivery of PSPV ... compliance and training team + Escalate issues / problems to line manager as needed. **Education & Competencies (Technical and Behavioral):** + Bachelor's degree… more
- Actalent (Cambridge, MA)
- …- Serve as a primary liaison and point of contact for vendor operations and vendor oversight including vendors performing case management case intake ie Call Centers ... scientific literature review etc. - Oversee operations performed by the PV BPO vendor including contract compliance quality and timeliness of deliverables. - Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Embark on a transformative journey with Taiho Oncology as a Manager , Pharmacovigilance , QST, Contracts and Operations At the forefront of ... Manager , PV QST Contracts & Operations Princeton, NJ, USA Req...pharmacovigilance innovation, we offer a dynamic and collaborative environment where your… more
- Ascendis Pharma (Palo Alto, CA)
- …of the Head of Global PV Operations, is responsible for overseeing Pharmacovigilance requirements for assigned vendors. Key Responsibilities + Lead & guide the ... development and execution of Pharmacovigilance strategy and tactics in alignment with key stakeholders...risks as appropriate to vendor owner, SP PV Oversight Manager and/or SP PV Oversight Head. Accountable for PV… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- Job Title Pharmacovigilance Intern Requisition JR000014766 Pharmacovigilance Intern (Open) Location Webster Groves, MO Additional Locations Job Description ... at Mallinckrodt and gain the real-world experience you are seeking. Summary + The Pharmacovigilance (PV) Summer Intern will assist in the functions of the SpecGx LLC… more
- Merck (Rahway, NJ)
- **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case review/approval ... management + Support training + Provide business support for pharmacovigilance database systems (eg, review validation documents and execute...needed + Participation in projects as agreed with the manager This position is based at our Rahway, NJ… more
- Daiichi Sankyo Inc. (Atlanta, GA)
- …relevant to the marketplace, competition and the marketing team to the District Manager . + Notifies the Medical Affairs Pharmacovigilance immediately of any ... around rare diseases and immune disorders. **Summary:** The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory … more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr. Manager , PV Compliance and Vendor Quality (Ref: 4360), Bristol-Myers Squibb Company, ... Princeton, NJ.** Provide quality oversight through ongoing monitoring of Global Pharmacovigilance with a focus on quality related aspects of the safety by drawing on… more
- United Therapeutics (Research Triangle Park, NC)
- …You have a background in nursing or pharmacy and you're passionate about pharmacovigilance . You are a team player who loves quality, compliance, finding solutions ... practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **The Senior Manager ,** **GPV Compliance & Business Management will support the** **leads of Global PV** **Audit & Inspection readiness** **(AIR)** ... role will work** **collaboratively with other stakeholders from Global Pharmacovigilance ** **(GVP) groups, Affiliate PV** **Coordination Group (APVC), Global… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …more than 110 countries and regions. **Position Overview:** The Medical Information Sr. Manager is a member of the US Affiliate Medical Affairs department. The ... Medical Information Manager is a hybrid-based (eg office and remote-based professional...Medical Affairs Teams and other Grifols stakeholders (eg, Quality, Pharmacovigilance , RandD etc.) to develop and maintain a library… more
- BeiGene (San Mateo, CA)
- …IRBs/ECs. . Assist with integrated Benefit/Risk assessments Promote and Advance the Field of Pharmacovigilance . Any other tasks assigned by manager to assist in ... **_General Description:_** The Senior Manager , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) to conduct signal… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Operations & Excellence (Strategy & Structure) plays a critical role in structuring and executing quality ... enhancements through digital innovation and change management. The Senior Manager will ensure cross-GxP strategic alignment and facilitate communication between… more
- Nestle (Bridgewater, NJ)
- …health and nutrition for patients and consumers. **Position Summary:** The Sr Manager , Case Management Vendor Oversight is responsible for developing and maintaining ... to the development and implementation of processes and procedures for pharmacovigilance and safety operations. They also ensure successful governance of key… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Quality Process Manager Date: Mar 7, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance ... related to safety variations submission) from RIMS to be included in the Pharmacovigilance System Master File **Experience Required** + 4 years in Scientific related… more
- BeiGene (San Mateo, CA)
- …responsibilities not specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related duties that ... integrated Benefit/Risk assessments. + Promote and Advance the Field of Pharmacovigilance . + Responsible for effective execution, communication and influence with… more
- Chiesi (DE)
- Manager Information & Regulatory Affairs (all genders) Abteilung: Pharmaceutical Affairs Team: R&D, Pharmacovigilance & Regulatory Affairs Stellentyp: Direkter ... entlang der gesamten Wertschopfungskette zu erreichen. **Wir suchen ab sofort eine*n Manager Information & Regulatory Affairs (all genders) in Hamburg.** Ziel der… more
- Amgen (Charlotte, NC)
- …Let's do this. Let's change the world. In this vital role the Case Manager will experience day to day oversight and awareness of patient customer service issues ... gain access to therapy + Partner with Safety and Pharmacovigilance (PV). Report Adverse Event (AE)'s and product complaints...industry + 2+ years prior experience as a Case Manager + Excellent communication skills and commitment to customer… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Operations & Excellence (RDQ Operations) is responsible for implementing and maintaining a balanced, ... processes and the associated strategy, metrics, and optimization. The Senior Manager can be assigned to manage Significant Quality Events (SQEs), Corrective… more
- Takeda Pharmaceuticals (Boston, MA)
- …and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies Business Unit (PDT BU) is a key role in ... and guidance to internal stakeholders, including Clinical, Device Development, Pharmacovigilance , Legal, Scientific, Commercial, to ensure successful development and… more