- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Manager, Pharmacovigilance Department: Pharmacovigilance Location: Elmwood Park, NJ START YOUR APPLICATION ... in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient,… more
- GE HealthCare (IL)
- **Job Description Summary** The Pharmacovigilance Agreement Associate , working on the Global Pharmacovigilance Team, will be responsible for supporting the ... preparation and maintenance of GE HealthCare Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and other related contractual … more
- Lilly (Indianapolis, IN)
- …system change management process for PV systems. + Perform configuration of PV safety systems such as global reporting rules and conducting Product License Study ... activities. PV Data Reporting & Compliance + Provide PV and Lilly safety reports through existing/adhoc queries with high quality and accuracy through appropriate… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical ... sources of safety information under the guidance of the Manager, Pharmacovigilance . Sources may include recorded calls, claims, faxes, text messages, chat logs,… more
- Taiho Oncology (Princeton, NJ)
- …part of our team, you'll have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and advance patient care worldwide. With ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of... Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment… more
- Lilly (Indianapolis, IN)
- … & Pharmacovigilance Technology:** Lead the enterprise strategy for drug safety technology systems, ensuring world-class pharmacovigilance capabilities ... a leader in pharmaceutical innovation, we are seeking an Associate Vice President (AVP) - Patient Safety ... Pharmacovigilance Technology** Own the enterprise strategy to drug safety and pharmacovigilance technology… more
- AbbVie (North Chicago, IL)
- …signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance , supporting all patient safety activities. Responsibilities: ... to effectively conduct safety surveillance * Conducts safety surveillance for pharmaceutical/biological/ drug -device combined products; contributes to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... **Description** Director OR Senior Associate Director has responsibility for the pharmacovigilance...compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:… more
- Ascendis Pharma (Princeton, NJ)
- …8 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and ... + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements...health care field with relevant pharmaceutical industry experience in drug safety . + Candidates with advanced scientific… more
- Astellas Pharma (Northbrook, IL)
- …teams. 1. ** Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. + Develop ... diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key… more
- ThermoFisher Scientific (Greenville, NC)
- …background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in ... experience working on clinical trials through every stage of drug development. This includes management and oversight of all...years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) **For Medical… more
- System One (East Windsor, NJ)
- Job Title: Quality Compliance Associate Location: East Windsor, New Jersey Type: Contract Compensation: $26 - $36 per hour Contractor Work Model: Onsite Hours: 8/9 ... Sterile Injectable Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be… more
- Amgen (Washington, DC)
- …Join us 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 ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO. + Support activities related to new drug applications and other regulatory filings: Assist GSO in… more
- Parexel (Columbia, SC)
- …of Medical Monitoring and study design/execution, preferred * Good knowledge of the drug development process including drug safety , preferred * Excellent ... expanding our esteemed Medical Sciences Team and seeking an Associate /Medical Director to support the growth of our Global...clients in the journey of getting new and innovative drug treatments into the hands of those who need… more
- Sumitomo Pharma (Annapolis, MD)
- …including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety ... a dynamic, highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology** . The associate … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety , Clinical Sciences, Outcomes, Digital Health, Pharmaceutical ... clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science, Neuroscience- Pulmonologist/Neurologist in our Cambridge, MA ... a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global… more
- Lilly (Indianapolis, IN)
- …thinking, and decision-making skills. + Proven track record of successfully managing drug safety operations in a biotechnology or pharmaceutical company. + ... and data exchange between clinical trial management systems (CTMS), safety databases, commercial pharmacovigilance platforms, and regulatory submission… more
- Bristol Myers Squibb (Princeton, NJ)
- …(SBRA) Lead will report into the Structured Benefit-Risk Assessment Head within Safety Evidence and Sciences and will be accountable to lead structured benefit-risk ... collaboration with relevant departments across the organization, including medical safety assessment, clinical development, global regulatory, epidemiology and others.… more
- AbbVie (North Chicago, IL)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be… more
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