- Tris Pharma (Monmouth Junction, NJ)
- …and leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management strategies in pre and ... safety reports, periodic safety reports, signal detection activities and risk management planning....BSN, PA, NP, PharmD, etc.) and minimum 7 years global Drug Safety /Pharmacovigilance clinical trial and post… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important safety topics, and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...will ensure proactive safety monitoring and risk management through the Safety Management … more
- Aequor (San Diego, CA)
- …with safety activities in drug development and postmarketing and global safety health authority requirements.Working understanding of team priorities and ... deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CSPV epidemiology group aims to provide strategy leadership in safety signal detection and evaluation, risk management , and post-marketing epidemiological ... Executive Director, the sub-functional lead for Epidemiology group in Global Medical Safety , leads and manages the...group in order to provide adequate epidemiology support in safety signal detection, evaluation and RMP for… more
- Lilly (Indianapolis, IN)
- …of Global Patient Safety 's capabilities in the field of device safety . **Primary Responsibilities:** Device Signal Management and Risk Management ... and Device Safety Physician to facilitate appropriate signal management of device safety ...eg epidemiology, toxicology, pharmacovigilance, regulatory affairs + Experience within Global Patient Safety or demonstrated knowledge and… more
- Lilly (Indianapolis, IN)
- …Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level. + Provide ... Medical Advisor is to perform medical roles within the Global Patient Safety (GPS) Medical function. These... of assigned product(s) including surveillance programs and risk management planning. Ensure proactive safety surveillance: lead… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management , communication of the safety ... The Global Patient Safety (GPS) lead role...matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Global Safety Officer (GSO), Global Safety Medical Director, Oncology, ... deliverables for assigned products. You will also lead the Safety Analysis Team (SAT), Global Safety...for the Therapeutic Area Head (TAH). **Responsibilities:** + Validate safety signals and lead safety signal… more
- BeiGene (San Mateo, CA)
- …for action. + Lead signal assessment and documentation following BeiGene signal management and safety governance framework. + Demonstrated ability ... around safety scientist core responsibilities including: + Signal detection and signal management ...global regulatory requirements for pharmacovigilance. + Prior people management experience is a plus. + Prior experience with… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management , communication of the safety ... Reporting to the Global Patient Safety (GPS) Therapeutic Area...Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Global Safety Team (GST) Chair (Medical Director). The Manager, Drug Safety will perform signal management process activities for assigned products, ... safety interactions/responses for assigned MTPG products regarding safety and risk management , both written and...global regulatory requirements related to pharmacovigilance and drug safety . + Strong knowledge in signal detection,… more
- Amgen (Washington, DC)
- …data for the purpose of signal detection + Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional ... team meetings as requested or needed + Signal detection, evaluation, and management - Perform data analysis to evaluate safety signals and write up analysis… more
- Taiho Oncology (Princeton, NJ)
- …with Medical Surveillance Physicians towards adhoc and routine Global Safety Management Team (GSMT) meetings. + Lead signal management activities in ... biotechnology or related environment, + Proficiency in signal detection, safety surveillance, risk mitigation and risk management . + Experience directly… more
- BeiGene (Emeryville, CA)
- …issues and strategy + Execute signal assessment strategy and prepare presentations for Safety Management Team and Company Safety Committee + Prepare and ... an authoritative and professional member of relevant teams. Supports signal evaluation/ safety monitoring activities and contributes and...present safety data at safety governance meetings ( Safety Management … more
- BeiGene (San Mateo, CA)
- … assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee + Lead the ... an authoritative and professional member of relevant teams. Supports signal evaluation/ safety monitoring activities and contributes and...preparation and presentation of safety data at safety governance meetings ( Safety Management … more
- Global Foundries (Richardson, TX)
- …on GLOBALFOUNDRIES silicon. Essential Responsibilities: + Collaborate with product management and end markets to define critical performance requirements for ... activities in a safe and responsible manner and support all Environmental, Health, Safety & Security requirements and programs + Guide and mentor junior engineers in… more
- AECOM (Detroit, MI)
- …+ ITS used properly (AID notifications, ICM activated, VSL activated) + Arterial Management + Traffic Signal Optimization + QA Intersections + Suggest changes ... ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists,...**Job Description** **AECOM ** is seeking a Transportation Systems Management and Operations ( **TSMO) Technician** to be based… more
- J&J Family of Companies (Raritan, NJ)
- …and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety ... products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including...drugs both on the market and in development and global safety regulations highly preferred * Ability… more
- Lundbeck (Deerfield, IL)
- …Leads the safety surveillance activities for products assigned to the Global Medical Safety -US organization including the preparation/submission of IND and ... NDA Annual, PSUR, PBRER, RAR). + Maintains oversight of signal detection, risk management activities and REMS...surveillance projects within GPS in line with GPS and Global Medical Safety strategies + Utilizes subject… more
- BeiGene (San Mateo, CA)
- …important developmental programs and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the ... of, and handling of product safety concerns **Governance** + Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT Materials,… more
