- Russell Tobin & Associates (South San Francisco, CA)
- …review of US Patient Safety cases and support US Patient Safety PV Clinical Manager _ ICSR Case Management in all activities. Requirements: Health Care ... (eg RN/BSN/MSN, NP, Rph/B Pharam/Pharm D, or MD) required 2+ years of clinical / Pharmacovigilance experience depending on education level Medical writing… more
- Russell Tobin & Associates (San Diego, CA)
- …of QC of clinical trials execution in a GCP regulated environment Support Drug Safety Pharmacovigilance , Computer System Validation and GLP Work closely with ... for clinical trial related processes and procedures Lead or support implementation of suggested improvements Requirements: Bachelors or Masters degree in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Product Team Lead (EPTL), and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across ... and regulatory aspects of the products to provide medical, clinical and scientific support , mentoring and leadership...& Leadership** + Partner with R&D Marketed Product Project Manager to coordinate R&D function support for… more
- Johns Hopkins University (Baltimore, MD)
- …Research Site Manager_** who will deliver to and organize work plans with collaborating 20+ clinical sites across the country in support of clinical trial ... teams on schedule with established performance expectations. + Provide support to quality assurance monitors in all facets of...+ Experience in a higher education environment. Classified Title: Clinical Research Site Manager Job Posting Title… more
- Editas Medicine (Cambridge, MA)
- …and pharmacovigilance , and is responsible for protocol development and clinical sections of regulatory documents (e,g. IND submission, briefing documents, study ... position reporting to the Chief Medical Officer will lead clinical development for Editas' expanding clinical portfolio...The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves'… more
- BeiGene (Emeryville, CA)
- …signal detection and signal assessment along with required documentation following BeiGene process ** Clinical Trial Support ** + Conduct review of safety data and ... + Assist with integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in… more
- AbbVie (North Chicago, IL)
- …who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, ... representative for key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team ( Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, ... Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans or similar documents, Core Clinical Trial Protocols,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... evidence, and creating hope for all facing illness. The Manager , Drug Safety Aggregate Reports will function as the...and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager ** Internal posting title: Deputy Country Safety Head, US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** Full ... of the CSH. + Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. +… more
- BeiGene (San Mateo, CA)
- …evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and ... the monitoring of the safety of patients on allocated clinical trials. + Lead the development of safety contents...approval of amendments and contribute to safety summaries to support changes to the CCDS. + Contribute to development… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Manager , Drug Safetywill support signal detection activities and medical analyses ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- AbbVie (North Chicago, IL)
- …reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety, Epidemiology & R&D Quality Assurance ( PSEQ) organization's ... of the PST model. As an Epidemiology Study Operations Manager within the Office of the PST, you will... within the Office of the PST, you will support and partner with the Global Epidemiology organization to… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …is to support the Global Patient Safety (GPS) department in business support of safety systems utilized for pharmacovigilance . This includes overseeing daily ... FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities + Familiarity with… more
- J&J Family of Companies (Malvern, PA)
- …Monitor inspections + Act as CRM single point of contact for cross-functional and clinical trial teams and provide support on GCP/quality issues + Conduct ... ONCOLOGY RISK MANAGER - 2406184745W **Description** Janssen Reseach and Development...oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring requirements. Works closes with other functional groups such as… more
- Regeneron Pharmaceuticals (Armonk, NY)
- … Development role. Strong Expertise with transferable skills related to Good Clinical Practice(GCP), and/or Good Pharmacovigilance Practice (GVP). Does this ... The Senior Manager , Global Development Quality Management (GCP) acting as...GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous… more
- AbbVie (Boston, MA)
- …for three or more compounds in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of Safety Statistical Programming is a strategic role in the emerging… more
- Pfizer (Tampa, FL)
- **Role Summary** The Audit Manager , Research, Development and Supply will be part of Pfizer Corporate Audit's internal team that provides "third line of defense" ... Chain to plan and execute best in class audit assurance. The Audit Manager is responsible for identifying risks in specific business areas and conducting independent… more
