- 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 ... it relates to innovative safety science and pharmacovigilance . + Demonstrated Project and Vendor Management...English. + Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to global process improvements. Develops and provides mentorship to enable project teams to embrace pharmacovigilance initiatives and strategic remits. ... Patient Safety within Gilead; Identifies and leverages advances in pharmacovigilance where appropriate, such as use of artificial intelligence, real-world data,… 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
- 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
- Pfizer (New York, NY)
- …ensure the quality and reliability of AI systems that may affect pharmacovigilance . This involves contributing to and participating in various quality oversight ... to drive discussion and action related to mitigating risks to the pharmacovigilance system from the use of artificial intelligence. The incumbent leads PVQO… more
- BeiGene (San Mateo, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- Takeda Pharmaceuticals (Boston, MA)
- …with requisite global and local regulations and requirements. As part of the Patient Safety & Pharmacovigilance (PSPV) team, you will report to the Director and ... motivating and developing people. + Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis. +… more
- BeiGene (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- Bristol Myers Squibb (Princeton, NJ)
- …guidelines, including the FDA, ICH, & EU Regulations & Requirements for Pharmacovigilance ; Pharmacovigilance (PV) Safety Database; case processing, including ... . Employer: Bristol-Myers Squibb Company Position: Sr. Manager, Medical Device Safety (Ref: 4185) Location: 3551 Lawrenceville Road, Princeton, NJ 08540 **Duties:**… more
- Lundbeck (Deerfield, IL)
- …EDUCATION, EXPERIENCE, and SKILLS:** + Accredited MD/DO (MBBS, MBCHb, MBBCh) + 5+ years drug safety experience in a biotech or pharmaceutical company + Ability ... Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. The incumbent will have a strong background...to drive drug safety evidence generation and risk mitigation… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …and assess across products and/or device associations. + Partner with Global Product Safety and Pharmacovigilance to assess complaint and AEs for the potential ... Description: Drug Device Combination Product Manager is a position...risks through early detection and mitigation, working closely with project leads, site quality, manufacturing, and regulatory functions. This… 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
- 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 from post-marketing sources, providing medical expertise to assigned project teams, the identification and investigation of safety...+ Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …minimum of 6 years' experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ICSRs. + Extensive knowledge of US ... Safety Reporting. + Industry experience of clinical safety , pharmacovigilance operations, and medical review. Oncology...Board certification is strongly preferred. Significant experience working in drug safety / PV or a related… more
- Merck (North Wales, PA)
- …The Global Clinical Trial Operations (GCTO) team is seeking applicants for the Project Management Office intern position. The intern will engage with the Project ... GCTO. **Activities may include (but are not limited to):** + Provide project management support for strategic initiatives + Assist organizational efforts to simplify… more
- AbbVie (Chicago, IL)
- …must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety , Data Analytics, Medical Writing, Regulatory ... across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVie's SOPs, department, and project standards. +… more
- AbbVie (North Chicago, IL)
- …) must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety , Data Analytics, Medical Writing, Regulatory ... across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVie's SOPs, department, and project standards. +… more
- AbbVie (North Chicago, IL)
- …support. + Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable, not required. + Familiar with working in ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Safety Data Scientist partners with cross functional stakeholders in support of the… more
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