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Drug Safety Jobs in Chinatown, NY

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Schedule Details/Additional Information:.

11926 AMC Grafton - Public Safety

Status:.

30+ days ago

Paramus, NJ
  • $300,000–$350,000 / year

We are consistently ranked by U.S. News & World Reports Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

30+ days ago
Philips logo
New

NY
  • $133,000–$212,000 / year

This role makes harm severity and IMDRF coding determinations and drives continuous improvement initiatives in post market surveillance activities, collaborating with technical experts to resolve issues and support corrective actions.

The Medical Safety Manager, Complaints Handling, performs clinical assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical liaison between Post Market Surveillance and Medical Safety, facilitating escalations as necessary.

5 days ago

New Brunswick, NJ
  • $175,000–$275,000 / year

p>Required Background Experience & Competencies Broad-based knowledge of the full scope of quality and regulatory strategy as it applies to an accredited academic medical center or primary teaching hospital of comparable size and scope High-level, complex problem-solving abilities both in groups and in one-on-one situations Ability to translate the mission and vision to everyday work Ability to manage and lead in a matrixed organization Ability to cultivate and foster relationships at every level of the organization (locally at the hospital, within the system, and board relations) Demonstrated success in leading system process improvement initiatives in an academic quaternary care facility Decisive leader, with the ability to understand patient and clinician stakeholder viewpoints and needs and work strategically in the best interest of patients and the organization A strong reputation for sustained, inclusive, trust-based relationships with employees, clinicians, patients, and the community Experience in a system with excellent employee, physician, and patient satisfaction, quality, and clinical outcomes An understanding of information systems as they pertain to clinical excellence, decision support, efficiency, and effectiveness Strong leader of people with the ability to create an environment that supports team morale, improved service, and the highest quality Exhibit strong communication, presentation, and listening skills to ensure facility-wide collaboration and coordination.

Patient Safety Assume the role of the Patient Safety Officer overseeing patient safety programs, managing risk, and responding to adverse events Serve as the hospital leader for campus-related occurrence reporting and safety events High Reliability Organization (HRO) Executive Delegate in partnership with system leadership Regulatory Policy and Procedure Executive Sponsor - Oversee the creation and implementation of policy and procedures across the organization This includes staying up-to-date on regulatory requirements and ensuring that the hospital is in compliance with all applicable regulations Facilitate Organizational survey preparedness Administrative Lead for organizational licensure, Certificate of Need, Regulatory Executive Reviewer (all agencies).

30+ days ago

Valhalla, NY
  • $72.76–$81.90 / hour

This role leads proactive and reactive safety initiatives across all but not limited to clinicâbased ambulatory care, retail, specialty, mailâorder, infusion centers, and pharmacist-led ambulatory services. Job Details: Job Summary: The Medication Safety & Regulatory Compliance Pharmacist is responsible for designing, implementing, and monitoring medication safety programs and ensuring ambulatory pharmacy compliance with state and federal regulations.

30+ days ago
Philips logo

  • $133,000–$212,000 / year

li>Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

23 days ago

NJ
Remote
  • $133,000–$173,000 / year

p>For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. Reporting to the Senior Director, DSPV Operational Excellence and Compliance, you'll be responsible for the end-to-end development, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs).

30+ days ago

NY
  • $285,000–$330,000 / year

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Additionally, you will play a key role in supporting drug safety and pharmacovigilance activities to ensure high-quality data generation to support the safety and efficacy of our products in development.

27 days ago

NJ
  • $70,000–$95,000 / year

li>Determine and perform appropriate case follow-up activities including generation of follow-up requests via fax, phone, mail, or e-mail and product complaint notifications to consumers, HCPs, Specialty Pharmacies and/or vendors.

Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

30+ days ago
New

Piscataway, NJ
  • $90,000–$110,000 / year

li>Medical Affairs: A designated representative from the Medical Safety Science Department with technical expertise to verify the medical and scientific integrity of the Asset or Communication and to ensure that medical and/or scientific information contained in the Asset or Communication is accurate and not misleading, medically relevant, supported by the references provided, well-substantiated by scientific data, truthful and balanced, and scientifically rigorous.

Additional Responsibilities:

  • Medical Affairs: Team lead for medical affairs sub-groups for MIRF (Medical Information Request Forms): Information request from HCP''s which are submitted by IMPAX sales reps and MSLs and these requests are managed by medical affairs using SRL''s and escalated to MSL''s if required.

6 days ago

  • $192,000–$264,000 / year

argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

  • Demonstrated experience using digital tools and automation to improve efficiency, visibility, and oversight across regional pharmacovigilance activitiesExcellent oral and written communication skills.

    • 24 days ago
    Sanofi logo

    Morristown, NJ
    • $178,500–$257,833.33 / year

    p>Experience / Skills:

    • MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization.

      On Clinical Development, the CRD:

      • Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.

    30+ days ago

    NY
    Remote
    • $72,000–$100,000 / year

    Assess ICSRs for individual adverse event terms signifying seriousness and expectedness relative to the product label while also referencing guidance documents provided by regulatory authorities on assessing seriousness. At least 2 years experience working in Pharmacovigilance, a Contract Research Organization (CRO) or other related scientific area; with specific experience working with Medical Devices, preferred.

    30+ days ago

    NY
    • $175,000–$215,000 / year

    p>Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders.

    Our broad therapeutic pipeline based on the company's proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.

    12 days ago

    Jersey City, NJ
    • $270,000–$294,500 / year

    p>In partnership with your Manager:

    • Design and conduct early-stage or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.

    This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey offices to ensure effective collaboration and high-quality execution of your clinical work.

    30+ days ago

    NY
    • $170,000–$215,000 / year

    Sionna's goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR's nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. The AD PV Scientist will lead or contribute to key PV deliverables and activities associated with signal detection and management, benefit-risk evaluations and regulatory and aggregate safety reporting processes, PV SOP development and management, and oversight of the PV vendor and Clinical CRO safety activities.

    30+ days ago

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