- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP group and its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from audits, health ... research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities… more
- Sumitomo Pharma (Lincoln, NE)
- …The Senior Manager , Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk Management (PVRM) point of contact for ... global development, and strategic partnerships. This role leads evaluation and risk management activities, ensuring adherence to safety governance for… more
- Colgate-Palmolive (Piscataway, NJ)
- …with partners + Support the Head of GPV in delivering a company-wide Risk Management System that includes organizational structure and supporting documentation. ... as the Lead point of contact for all Global Pharmacovigilance functions and processes for internal & external customers...appropriate personnel and stakeholders are engaged with the overall management of risk for our products globally.… more
- AbbVie (North Chicago, IL)
- …Purpose This individual will be responsible for leading and supporting Quality Risk Management (QRM) activities for AbbVie products such as Combination, ... met to support and sustain the Quality System in compliance to Quality Risk Management regulations, guidance's and standards. Responsibilities + Drive Quality… more
- J&J Family of Companies (Spring House, PA)
- …Early Development Clinical Risk Management . The Specialist Early Development Risk Manager works with the trial teams to support and/or coordinate the ... **Job Description:** Johnson & Johnson is currently seeking a Specialist, Early Development Risk Management to join our Clinical Research Management team… more
- BeOne Medicines (San Mateo, CA)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... Safety Update Reports (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) + Provide high quality support and fulfill… more
- BeOne Medicines (Emeryville, CA)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related...(PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). + Lead and… more
- AbbVie (North Chicago, IL)
- …the safety profile of our drugs to protect patients worldwide. The PST Project Management group (PST PM) plays a critical role in shaping and driving the strategic ... priorities of Patient Safety through providing exceptional and strategic project management leadership across the PST. The PST is a high-profile high-impact team… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in clinical study team meetings for assigned compounds + Participate in other risk management activities as appropriate for assigned compounds + We may ... The Senior Manager of Global Patient Safety (GPS) will play...Master's, PhD, or PharmD + 7+ years of relevant risk management experience in the pharmaceutical/ biotech… more
- Organon & Co. (Plymouth Meeting, PA)
- …of women globally. We are looking for an experienced Associate Director, Program Management to join our team. This successful candidate will provide program ... management expertise as an individual contributor to teams leading...drugs or devices which improve human health. The Program Manager may also be assigned to projects that contribute… more
- Pfizer (New York, NY)
- …respective Disease Area(s) + Overseeing and performing proactive safety surveillance and risk management to effect product safety signal detection & evaluation, ... risk minimization + Working with other Pfizer functions engaged in benefit- risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable… more
- AssistRx (Orlando, FL)
- …of the Compliance Department including hotline responses, internal controls, safety reporting/ Pharmacovigilance , document control, training, risk management , ... details of audit agenda and evidence requests with Operations, Account Management , Quality Assurance, Tech Org, and other applicable departments. + Partners… more
- Sanofi Group (Morristown, NJ)
- …+ Evolve Process Simplification & Ways of Working to maximize output & minimize risk . + Internal and External Stakeholder Management - KOL engagement oversight ... **Job Title:** US Transplant Medical Program Lead (MPL) **Grade:** L3 **Hiring manager :** Peg Bollella **Location:** Morristown, NJ **About the Job** Under the… more
- Sanofi Group (Cambridge, MA)
- …agencies + Demonstrated capability to challenge decision and status quo with a risk - management approach + Ability to negotiate to ensure operational resources ... Principal Clinical Research Director, I and I **Grade:** L5 **Hiring Manager :** Christopher Soria **Location:** Cambridge, MA Morristown, NJ **About the Job**… more