- Ascendis Pharma (Palo Alto, CA)
- …for assigned activities + Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as ... The Associate Director , Global PV Operations reports directly...Management Teams (SMTs) as an active member representing PV Operations team. + Participate in the conduct of… more
- Taiho Oncology (Princeton, NJ)
- …of a more complex nature and/or global products that are marketed with risk management programs. Performance Objectives: + Maintains expert knowledge of safety, ... Sr. Director , PV Medical Surveillance Princeton, NJ,...managing adverse event and SAE processing, medical surveillance and risk management , signal detection, on a global… more
- Ascendis Pharma (Palo Alto, CA)
- …foreign regulatory reporting requirements and for signal detection, evaluation and risk management . + Supports Pharmacovigilance Department direction, standards, ... Provides leadership to the development of safety surveillance and risk management plans for drug development programs....and tracking the responses. + Participate in relevant crisis management activities within the scope of Ascendis PV… more
- Bristol Myers Squibb (Princeton, NJ)
- …include single case and aggregate safety monitoring, safety reporting, contributing to benefit- risk assessment, risk management planning and strategy, ... draft summary documents. . Lead medical safety development and execution of benefit- risk management strategies for assigned products. . Provide safety input… more
- Lundbeck (Deerfield, IL)
- …and clinical trials, the detection and evaluation of safety signals and risk management activities. Additional responsibilities include contribution to the ... Medical Director Global Patient Safety (GPS) US - Remote...Safety Team members, as well as safety governance bodies ** Risk Management ** + Maintains oversight of … more
- Kelly Services (Alameda, CA)
- …compliance across GCP, PV , and GLP functions, ensuring data integrity through risk -based audits and Quality Risk Management (QRM). Key responsibilities ... ** Director of Scientific Affairs - Bay Area** Type:...for Product Development, offering guidance on data integrity and risk management . + Implement Quality Risk… more
- Merck (North Wales, PA)
- …work, uses advanced skill in performing safety surveillance activities and developing and evaluating PV activities, Risk Management Plans (RMP) and Risk ... **Job Description** Highly advanced understanding of safety and/or risk management to allow for overall...and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from… more
- Amicus Therapeutics (Marlow, OK)
- Senior Director , Global Quality Management Systems Location Marlow, UK Requisition ID 2276 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1322) Job Brief Senior Director - Global Quality Management Systems Amicus… more
- BeiGene (San Mateo, CA)
- **General Description:** The Director , GCP Inspection Management , is responsible for: + Supervising activities related to inspection readiness, hosting and ... PMDA, TGA, etc. + Developing, maintaining and ensuring the execution of a risk -based, proactive GCP Inspection Strategy + Ensure the development of inspection … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. + Ability to utilize ... in a matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific organization,… more
- AbbVie (Jersey City, NJ)
- …including but not limited to, medical safety assessments, regulatory responses and risk management plans + Apply current regulatory guidance as appropriate ... products in clinical trials and post marketing + Responsible for implementing risk management strategies for assigned products + Proactively engaging, inspiring,… more
- System One (Basking Ridge, NJ)
- …MD degree is acceptable) Client's JD: Position supports safety monitoring and risk management activities for products in development. This position will ... Associate Director , Clinical Safety MD Pharma In New Jersey...international MD is okay + 1-3 years of Pharmacovigilance ( PV )/clinical safety experience in pharmaceutical drugs either from relevant… more
- McKinstry (Salt Lake City, UT)
- …and EV Infrastructure across the private and public sector nationwide. + Risk management responsibility for project development including pricing, general ... ** Director of Regional Operations, Energy** Location **UT -...risk , and contractural risk . **_Management:_** + Recruits, trains, mentors and manages leaders… more
- ThermoFisher Scientific (Wilmington, NC)
- …reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities. + Medically reviews adverse event and ... pharmaceutical product life-cycle. **General Support:** + Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines… more
- BeiGene (Emeryville, CA)
- …and manages approval of PSUR/PBRER responses to HA + Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local RMPs ... The Executive Medical Director serves as the Lead Product Safety Physician...matrix team to conduct robust safety assessments and safety risk management activities, based on ICH standards,… more
- Amgen (Washington, DC)
- …sheet, core risks in informed consent forms, etc.) + Prepare/review core and regional risk management plans including additional risk minimization measures + ... a career you can be proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US - Remote** **Live** **What you will do** Let's do… 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 ... was possible. Ready to get started? The Clinical Research Director (CRD) is noted as the **primary clinical expert...other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps +… more
- Takeda Pharmaceuticals (Boston, MA)
- …and regulatory requirements and expectations. + Drive the implementation and change management of processes and systems across CPMQ + Create mechanism to monitor ... functional processes and systems + Create and implement change management plans for new and revised CPMQ processes and...communicated. + Ensure that risks captured on the CPMQ risk register are evaluated and escalated to the Quality… more
- AbbVie (Jersey City, NJ)
- …including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - safety component + Apply ... for periodic reports (DSURs, PSURs, PADERs etc.) + Responsible for implementing risk management strategies for assigned products + Proactively engaging,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current clinical practice ... reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician… more