- Novo Nordisk Inc. (Plainsboro, NJ)
- …a team of Medical Reviewers responsible for Medical Assessment of Individual Case Safety Reports and other safety reports pertaining to Novo Nordisk Products. ... a key Leadership Team member and advisor on Patient Safety Operations including handling of all safety ...for the Medical Review Team. Relationship Reports directly to Head of PV Case Management. This role involves the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …professionals, with inquiries, case handling issues, and process improvements related to patient safety . Relationship Reports to the Head of NNI Patient ... within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety , and centralized teams (eg, Training and Documentation, Quality, Supplier and… more
- GE HealthCare (IL)
- …with regulatory requirements. This role will report to Head of Global Pharmacovigilance and Drug Safety within the GEHC Global Medical Services ... **Job Description Summary** The Head of Pharmacovigilance at GE HealthCare...trained Pharmacovigilance Physician to lead and support drug safety activities across the United States… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in ... background. **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- …About the Job This role reports to the Regional Pharmacovigilance Head - North America. The successful individual ... in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient,… more
- Kelly Services (South San Francisco, CA)
- …Overview:** The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for ... contribute to the overall strategy and approach within Medical Safety by assisting the department head . Note...good pharmacovigilance practices and current regulations within drug safety . + Working knowledge of validated… more
- Ascendis Pharma (Princeton, NJ)
- …B. Pharm, PharmD, RN etc.) + Candidates with advanced scientific degrees and extensive drug safety experience is highly desired. + Minimum of 10 years recent ... Head , Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the ...people management experience (preferred). + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience… more
- J&J Family of Companies (Raritan, NJ)
- …Description:** Johnson & Johnson, is recruiting for a Executive Director, Therapeutic Area Safety Head , Cardiopulmonary to be located in Raritan, NJ; Titusville, ... way. Learn more at https://www.jnj.com/innovative-medicine The Therapeutic Area (TA) Safety Head , Johnson and Johnson Innovative Medicine...TA, both written and verbal + Ensure compliance of drug safety activities and processes with global… more
- AbbVie (North Chicago, IL)
- …+ Advanced degree required (MD, PharmD, PhD) with 8-10 years of experience in Pharmacovigilance and Drug Safety - in industry/academia and comprehensive ... candidate, with periodic travel to Lake County, IL (Abbvie Headquarter) Purpose: The Head of Cross Therapeutic Area Safety Science will drive AbbVie's mission… more
- Astellas Pharma (Cambridge, MA)
- …with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of ... ** Head of Solid Tumor Clinical Development** Do you...publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing,… more
- AbbVie (South San Francisco, CA)
- … safety . + Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on ... part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product ...AbbVie is seeking an experienced statistician to serve a Safety Statistics Group Oncology TA Head in… more
- Ascendis Pharma (Princeton, NJ)
- …identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable ... employees to grow and develop their skills. The Program Safety Lead reports to Head of Global...GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… 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
- Ascendis Pharma (Princeton, NJ)
- …8 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and ... Head , ICSR Management Team within the Global Patient Safety (GPS) organization. Under the direction of the ...health care field with relevant pharmaceutical industry experience in drug safety . + Candidates with advanced scientific… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in ... day might include:** + Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head , the...the therapeutic area of interest. + Thorough understanding of drug development and context as applicable to safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...analyses of safety information, in support of safety update regulatory submissions, investigational and new drug… more
- Amgen (Washington, DC)
- …functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians. **Responsibilities:** + ... input to protocols, statistical analysis plans, and clinical study reports + Prepare/review safety sections of new drug applications and other regulatory filings… more
- Ascendis Pharma (Palo Alto, CA)
- …4 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and ... of absence. The ICSR Management Lead reports to the Head , ICSR Management within the Global Patient Safety...health care field with relevant pharmaceutical industry experience in drug safety . + Candidates with advanced scientific… more
- CSL Behring (King Of Prussia, PA)
- …to ensure regulatory strategies align with current and emerging requirements. * ** Safety and Pharmacovigilance Intelligence** Monitor, track and analyze global ... three days a week. You will report to the Head of Global Regulatory Science and Policy. **Position Description**...role is to lead the advancement of regulatory and safety intelligence. This will be achieved in close collaboration… more
