- Merck (North Wales, PA)
- …understanding of business system management as well as other areas of pharmacovigilance / drug safety. Participants will be provided various opportunities to learn ... your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance (PV) Business System Management and Innovation team is seeking a… more
- Merck (Rahway, NJ)
- …from due diligence through implementation as well as other areas of pharmacovigilance / drug safety. Participants will be provided various opportunities to learn ... your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance Partner Strategy & Management (PV-PSM) team is seeking a summer… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …combination of education and experience + Minimum of 5 years of experience in pharmacovigilance , drug safety, or a related field. + Experience in managing safety ... on real-world evidence, and creating hope for all facing illness. As a Manager, Drug Safety Data, you will be responsible for managing and analyzing safety data to… more
- Takeda Pharmaceuticals (Boston, MA)
- …other relevant health-related field plus 10+ years of relevant experience in drug safety/ pharmacovigilance , or related fields. + Excellent communication and ... GPSE stakeholders. As part of the Patient Safety and Pharmacovigilance team, within the Risk Management and Education function,...English. + Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines. + In… more
- Taiho Oncology (Princeton, NJ)
- …responsible compounds, as well as regulatory guidelines as they pertain to drug safety/ pharmacovigilance . + Responsible for Individual Case Safety Report (ICSR) ... and Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event and SAE… 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 with ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Belcan (Arlington Heights, IL)
- …Nursing or Pharmacy * 5+ years" experience working within the Drug Safety/ Pharmacovigilance /Consulting domain including case processing experience, user ... gathering and user acceptance testing. * At least 3 years of pharmacovigilance systems experience. * Extensive experience with Argus Safety database including… more
- Kelly Services (Arlington Heights, IL)
- …Nursing or Pharmacy * 5+ years' experience working within the Drug Safety/ Pharmacovigilance /Consulting domain including case processing experience, user ... gathering and user acceptance testing. * At least 3 years of pharmacovigilance systems experience. * Extensive experience with Argus Safety database including… more
- GAP Solutions Inc (Bethesda, MD)
- …E (R2) - GCP regulations, and Human Subject Protection. + Expertise in clinical pharmacovigilance and drug safety, including CTCAE grading, MedRDRA coding, WHO ... evaluation, troubleshooting and maintenance of IT systems supporting the CROP Safety/ Pharmacovigilance and related programs. + Participate as required in the review… 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, WHO ... evaluation, troubleshooting and maintenance of IT systems supporting the CROP Safety/ Pharmacovigilance and related programs. + Participate as required in the review… more
- Randstad US (Philadelphia, PA)
- …or pharmacy) or a relevant scientific/technical discipline and experience. skills: Pharmacovigilance , Drug Safety, DSUR (Development Safety Update Report), RMP ... manner. qualifications: Minimum Requirements + At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Procedures + 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
- Randstad US (North Chicago, IL)
- …MHRA). + Competent in case processing processes, procedures, conventions. skills: FDA, Pharmacovigilance , Drug Safety, ICH Regulations, AD (Adverse Events) Equal ... 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 and Sales- ... their leadership. + Regulatory Affairs; Legal; OEC. + US Medical Information; Pharmacovigilance . + Library Information Resources. + Regionally and HQ based GAMA… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …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, but not required… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …Affairs + Clinical Development + Biostatistics + Clinical Pharmacology + Pharmacovigilance / Drug Safety Intra-Cellular Therapies is an Equal Employment ... Microsoft office applications (Word, Excel, PowerPoint) + Demonstrated understanding of the drug development process + Ability to travel at least 10% **Key… more
- Gilead Sciences, Inc. (Seattle, WA)
- …cross-functional projects and teams with responsibilities related to clinical trials, pharmacovigilance or other drug development activities. + Experience ... Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC). This specific role is… more
- Boehringer Ingelheim (Ridgefield, CT)
- …investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Continuous ... the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies + Contribute to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …applicable and appropriate + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Continuous ... **Description** Associate Director has responsibility for the pharmacovigilance risk management activities for marketed and/or investigational compounds on a global… more
- Gilead Sciences, Inc. (Foster City, CA)
- … experience + 15+ years of biopharmaceutical industry drug development experience, early through late-stage development **Preferred Qualifications** ... and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all Gilead investigational and marketed products. The GHPS… more
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