- Parexel (Des Moines, IA)
- …comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team ... members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. more
- Capgemini (Chicago, IL)
- …& Responsibilities** As a Senior Consultant, you will act as a ** pharmacovigilance and drug safety expert** for pharmaceutical and biotech clients, supporting safety ... (small molecules, biologics, vaccines, advanced therapies) and integrate AI/ML into pharmacovigilance practices. Key Focus Areas + Pharmacovigilance and drug… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …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
- Boehringer Ingelheim (Duluth, GA)
- …Boehringer Ingelheim's high regard for our employees. The Veterinarian, Pharmacovigilance ensures pharmacovigilance compliance with all competent authorities ... US, and submit to appropriate authorities as required. May provide support to Pharmacovigilance (PV) Management in the area of ADE analysis, PV trending and/or… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's ... agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US… more
- PSKW LLC dba ConnectiveRx LLC (Pittsburgh, PA)
- …direct supervision of the department manager or supervisor, the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety ... that ConnectiveRx operates in a constant state of compliance with Pharmacovigilance activities. Responsibilities + Reviews written Adverse Event and Product Quality… 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
- US Tech Solutions (CA)
- …* Perform **quality review** of **external providers'** reconciliation tasks for clinical and post-marketing ( **medical information, product complaints, and ... This role will be 100 % remote. Candidates must posses **3 to 5 years of experience** or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a **structured… more
- AssistRx (Orlando, FL)
- …Our talented team members provide therapy and healthcare system expertise to help patients achieve better results from care. A growing organization, AssistRx views ... our people as our strongest asset. Join us as we continue to make a difference Overview: This role is responsible for leading the daily tasks associated with the company's copay assistance programs. Within this role, the Quality Assurance Specialist serves… more
- Taiho Oncology (Princeton, NJ)
- …Oncology as a Senior Manager in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise ... will support medical surveillance activities and maintain oversight for the Pharmacovigilance Sciences function within the PV department. This includes managing all… more
- Parexel (Olympia, WA)
- …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
- Boehringer Ingelheim (Ridgefield, CT)
- …Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or support… more
- Taiho Oncology (Pleasanton, CA)
- …as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise ... key internal and external stakeholders, in addition to resources on pharmacovigilance -related matters. Performance Objectives: + Lead aggregate reports (eg DSUR,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Description** The Senior Manager, Global Pharmacovigilance (GPV) Compliance & Business Management (CBM), will support in the development and implementation of ... necessary processes for the management of routine compliance activities within the pharmacovigilance organization. This is a global role. The job holder will also… more
- Taiho Oncology (Princeton, NJ)
- …Senior Manager, Global Labeling and PV Operations. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your ... to inspection readiness and supports Health Authority inspections of Taiho's pharmacovigilance function. + Participates in internal PV meetings (Process improvement… more
- Bayer (St. Louis, MO)
- …routine and submission PV activities) and compliance with health authority pharmacovigilance (PV) regulations around the globe through the effective and timely ... clinical scientist position with deep expertise in key topics in pharmacovigilance (eg drug-induced liver injury (DILI), reproductive toxicity, quantitative signal… more
- Ascendis Pharma (Palo Alto, CA)
- …about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to ... Science. You will play a pivotal role as the Program Safety Lead and pharmacovigilance expert for the Ascendis' endocrinology pipeline. As a key member of the Global… more
- Sanofi Group (Cambridge, MA)
- …that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us ... our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and… more
- Astrix Technology (Monmouth County, NJ)
- …across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to ... on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) +… more
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