- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let's do this. Let's ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO… more
- Sumitomo Pharma (Hartford, CT)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional… more
- Bristol Myers Squibb (Princeton, NJ)
- …clinical trials, and project management skills; and + Medical concepts, safety activities in drug development, postmarketing, global safety health ... and three (3) years of post- baccalaureate experience. Must have experience with/in: + Drug safety , medical writing, signal detection, scientific background,… more
- System One (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) + 5+ years Drug Safety / Pharmacovigilance experience + Advanced Tableau, Spotfire, ... Job Title: Pharmacovigilance Reporting Analyst Location: Lawrenceville, NJ Hours/Schedule: Hybrid...from the Source to Target + Support program and project team activities required to implement innovation initiatives. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Minimum of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural ... adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a ...+ Ability to lead teleconferences and meetings with excellent project management and organization skills + Proactive, takes initiative,… more
- Sumitomo Pharma (Nashville, TN)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters...+ Prepares and presents safety information (ie safety graphs, tables, and reports) to project … more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- ThermoFisher Scientific (Greenville, NC)
- …systems in a regulated environment, including those implemented in support of drug safety , training oversight, and documentation management. **Knowledge, Skills, ... for newly onboarded employees to ensure they understand PPD pharmacovigilance (PV) and project specific policies and...PV and QA Audit program in support of clinical safety and pharmacovigilance activities. + Advanced knowledge… more
- BeOne Medicines (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
- Astellas Pharma (Northbrook, IL)
- …RWE, modelling, simulation, machine learning teams from clinical trials and drug development process, and life cycle management, including medical affairs statistics ... packages. The VP will partner with key stakeholders in development, pharmacovigilance , clinical operations, medical affairs, and commercial strategy to drive an… more
- Boehringer Ingelheim (Ridgefield, CT)
- …antibody-based biotherapeutics, viral, and gene therapies. As the primary interface between global project teams and Nonclinical Drug Safety , the incumbent ... has oversight for the design and execution of nonclinical safety programs to support the development of drug...stages to support asset progression through development; pro-actively manage safety liabilities. + Deliver updates to Project … 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 ... accountable for medical-scientific interpretations of aggregate data **Other Organizational Project Assignment** + Participation in relevant cross functional/GPS projects...to drive drug safety evidence generation and risk mitigation… more
- BeOne Medicines (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
- Rhythm Pharmaceuticals (Boston, MA)
- …with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical ... as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the… more
- Haleon (Warren, NJ)
- …digital projects) within assigned therapeutic category and/or business unit and represent safety function at project teams and other relevant cross-functional ... with a risk-proportionate framework for product vigilance, the **Associate Director, Consumer Safety Science** is accountable for developing the safety strategy… more
- Sanofi Group (Cambridge, MA)
- …(SMTs) + Communicate with and represent PV analyses and PV position within project /product teams, in safety governance and benefit-risk governance activities and ... **Job Title:** Global Safety Officer **Location** : Cambridge, MA **About the...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across ... various regions, offering guidance and support to each product safety team in critical areas such as individual case...expectedness of the adverse event in relation to the drug . Ensure all relevant data and findings are incorporated… more
- Bayer (Cambridge, MA)
- …further seamless clinical development. The IPML is responsible for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance and ... the full value chain from pre-D1 up to hand-over to late-stage drug development (following Proof-of-Concept and the decision to enter pivotal studies). The… more
- ThermoFisher Scientific (Austin, TX)
- …required). **Discover Impactful Work:** Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line ... globally to support training and end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle.… more
- ThermoFisher Scientific (Wilmington, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific… more
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