- Merck (North Wales, PA)
- …an understanding of business system management as well as other areas of pharmacovigilance / drug safety . Participants will be provided various opportunities ... company for your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance (PV) Business System Management and Innovation team… more
- Merck (Rahway, NJ)
- …from due diligence through implementation as well as other areas of pharmacovigilance / drug safety . Participants will be provided various opportunities ... company for your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance Partner Strategy & Management (PV-PSM) team is… more
- Takeda Pharmaceuticals (Boston, MA)
- …or other relevant health-related field plus 10+ years of relevant experience in drug safety / pharmacovigilance , or related fields. + Excellent communication ... as internal GPSE stakeholders. As part of the Patient Safety and Pharmacovigilance team, within the Risk...English. + Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.… more
- Ascendis Pharma (Palo Alto, CA)
- …Key responsibilities: + Assists Head of Global Medical Safety Science for drug safety and pharmacovigilance activities for ensuring corporate compliance ... Head of Global Medical Safety Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio.… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... and Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …a combination of education and experience + Minimum of 5 years of experience in pharmacovigilance , drug safety , or a related field. + Experience in managing ... creating hope for all facing illness. As a Manager, Drug Safety Data, you will be responsible... pharmacovigilance projects and initiatives. + Experience with pharmacovigilance databases and safety management systems. +… more
- Kelly Services (Arlington Heights, IL)
- …discipline, Nursing or Pharmacy * 5+ years' experience working within the Drug Safety / Pharmacovigilance /Consulting domain including case processing ... pharmacovigilance systems experience. * Extensive experience with Argus Safety database including experience with Argus Console, creating advanced conditions and… more
- Belcan (Arlington Heights, IL)
- …discipline, Nursing or Pharmacy * 5+ years" experience working within the Drug Safety / Pharmacovigilance /Consulting domain including case processing ... pharmacovigilance systems experience. * Extensive experience with Argus Safety database including experience with Argus Console, creating advanced conditions and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance , SVP Late Clinical Development and the ... working closely with other functional areas such as commercial, regulatory, pharmacovigilance , CMC, early clinical, and pre-clinical development in this regard. The… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …clients relating to Quality System regulations, Good Manufacturing Practices (GMPs), EU Drug Safety / Pharmacovigilance , and clinical trials preferred. + ... Expertise with fraud and abuse laws such as the US Anti-Kickback Statute, Foreign Corrupt Practices Act, and industry codes, such as the AdvaMed Code of Ethics preferred + Knowledge of global privacy and data protection laws such as HIPAA and GDPR is a plus,… more
- Randstad US (Philadelphia, PA)
- …(eg, nursing or pharmacy) or a relevant scientific/technical discipline and experience. skills: Pharmacovigilance , Drug Safety , DSUR (Development Safety ... Requirements + At least 8 years of experience in drug safety , including at least 5 years...literature databases for relevant information. + Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety . + Strong knowledge in signal ... safety topics for products working closely with Drug Safety Global Safety Team... safety conclusions, and their impact for product safety profile. + Mentor junior pharmacovigilance (PV)… more
- Randstad US (North Chicago, IL)
- …MHRA). + Competent in case processing processes, procedures, conventions. skills: FDA, Pharmacovigilance , Drug Safety , ICH Regulations, AD (Adverse Events) ... 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience. + Demonstrates ability to lead project work. Proven success… more
- AbbVie (Irvine, CA)
- …Operations Manager, Medical Managers/Advisers; Medical Information team / specialists; affiliate pharmacovigilance / drug safety personnel + Marketing ... their leadership. + Regulatory Affairs; Legal; OEC. + US Medical Information; Pharmacovigilance . + Library Information Resources. + Regionally and HQ based GAMA… more
- Kelly Services (Rockville, MD)
- …E (R2) - GCP regulations, and Human Subject Protection. + Expertise in clinical pharmacovigilance and drug safety , including CTCAE grading, MedRDRA coding, ... troubleshooting and maintenance of IT systems supporting the CROP Safety / Pharmacovigilance and related programs. + Participate as... Drug Dictionary. + Expertise in clinical trial drug safety regulations and guidelines in US,… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …Regulatory Affairs + Clinical Development + Biostatistics + Clinical Pharmacology + Pharmacovigilance / Drug Safety Intra-Cellular Therapies is an Equal ... Microsoft office applications (Word, Excel, PowerPoint) + Demonstrated understanding of the drug development process + Ability to travel at least 10% **Key… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Patient Safety within Gilead; Identifies and leverages advances in pharmacovigilance where appropriate, such as use of artificial intelligence, real-world data, ... **Capabilities & Requirements:** + Prior global leadership experience in a Patient Safety / Pharmacovigilance organization and broad R&D global functional… more
- Boehringer Ingelheim (Ridgefield, CT)
- …disciplines as appropriate + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing… more
- Merck (North Wales, PA)
- …pharmaceutical industry is required, with at least 5 years specifically involving safety experience (such as Pharmacovigilance or clinical work) involving direct ... **Job Description** Highly advanced understanding of safety and/or risk management to allow for overall accountability for the assigned cross-departmental process… more
- University of Colorado (Aurora, CO)
- …unresolved obstacles. ** Pharmacovigilance Support - 30%** Assists IND/IDE program's Pharmacovigilance Specialist in: + Reviews of adverse safety events and ... unresolved obstacles. ** Pharmacovigilance Support - 30%** Assists IND/IDE program's Pharmacovigilance Specialist in: + Reviews of adverse safety events and… more