- 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …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
- Merck (Rahway, NJ)
- …for interacting with health agencies (eg FDA); understand key elements in pharmacovigilance , drug safety monitoring, signal detection and processing ... of study findings; (b) **Global Regulatory Affairs and Clinical Safety :** Focus on late-stage and lifecycle drug ...Clinical Safety :** Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures… more
- Bristol Myers Squibb (Madison, 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