• GILEAD (Los Angeles, CA)
    …Working under direction the person in this position will ensure that local pharmacovigilance activities are conducted such that the affiliate is in compliance with ... Routine responsibilities will include as directed by the PVE Manager : Overseeing the local Quality Management System: * Ensuring...covered by a global PD. * Ensuring an after-hours process is in place locally for the receipt of… more
    Healthjobsnationwide (07/01/18)
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  • GILEAD (Foster City, CA)
    …cross-functional teams. Recruits, develops, and maintains key safety talent as line manager . Executes process changes and initiatives based on deep understanding ... analysis, and other ad hoc activities. Communicates to highest levels of senior management key pharmacovigilance findings. Provides global medical leadership for… more
    Healthjobsnationwide (07/01/18)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …escalating problems to Level III as needed. Supervisory/management/project manager experience preferred. This position performs SAE reconciliation, workflow ... and Procedures: Participates in development and update of case processing process guides.Qualifications Education and Experience * Bachelors in nursing, pharmacy, or… more
    Healthjobsnationwide (07/01/18)
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  • JobLeads (Washington, DC)
    …is an industry leading, single source provider for regulatory compliance, pharmacovigilance , and medical information services across the full development lifecycle ... with clients by providing leading industry knowledge, experience, and proven processes.The Senior Director of Compliance and Remediation will act as the Subject… more
    JobDiagnosis (07/05/18)
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  • GILEAD (Foster City, CA)
    …apply for this job. Job Description We are currently seeking an Associate Manager , Clinical Contracts & Finance with expertise in clinical outsourcing of global ... clinical sourcing), preferably in Oncology, Inflammation, Liver Disease and HIV. The Manager is responsible for the entire life cycle of vendor selection, including… more
    Healthjobsnationwide (07/01/18)
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  • Alkermes (Waltham, MA)
    The Executive Medical Director serves as senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned ... forums and initiatives. Executive Medical Director, Drug Safety and Pharmacovigilance (DSPV) The successful candidate will have demonstrated prior career… more
    Ivy Exec (07/04/18)
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  • Merck (Upper Gwynedd, PA)
    …Lead ensures quality principles are considered throughout the drug development process , risk mitigation strategies for programs underway are implemented and quality ... and efficient internal communication of resource and data quality matters to Senior Management as appropriate. This position will require approximately 30% time for… more
    Healthjobsnationwide (07/13/18)
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  • GILEAD (Los Angeles, CA)
    …Career Site to apply for this job. Job Description Regulatory Affairs Manager , Middle East Region based in Dubai Job Responsibilities Regulatory submissions * ... maintained in accordance with the product license. * Liaises with Global Pharmacovigilance & Epidemiology (PVE) and IRA regarding submission of urgent safety… more
    Healthjobsnationwide (07/01/18)
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  • UHG (Hopkins, MN)
    …than any hospital. Join us and start doing your life's best work.(sm) The Senior Director, Drug Surveillance and Pipeline , under the direction of the Vice ... Clinical Pharmacists and Business Analysts and serve as a dedicated pharmacovigilance leader responsible for drug surveillance, developing budget impact analyses,… more
    diversityjobs.com (07/14/18)
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  • BeiGene, Ltd. (San Mateo, CA)
    The Senior Manager or Associate Director of Inspection Management will be based in San Mateo or Emeryville, CA. This will be a hands-on position that will be ... responsible for the organization, planning, process and logistics of all health authority inspections. This will include, but not limited to, inspection readiness… more
    Ivy Exec (06/25/18)
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  • Atara Biotherapeutics, Inc. (South San Francisco, CA)
    We are seeking an experienced Sr. Manager / Associate Director, Medical Writing to join Atara Bio. The successful candidate is responsible for clinical regulatory ... to other regulatory documents and publications. Drives the document development process from gathering materials and developing scientifically rigorous content to… more
    Ivy Exec (06/23/18)
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  • Iovance Biotherapeutics, Inc. (San Carlos, CA)
    …clinical study teams. Review of scientific literature for safety signals/trends. Process clinical cases from unsponsored studies. May provide and prepare sections ... PharmD, or equivalent) with 5 years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry with experience in both… more
    Ivy Exec (05/25/18)
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  • Alexion Pharmaceuticals (Boston, MA)
    Position Summary The Senior Manager , Risk Evaluation and Mitigation Strategy (REMS) directs and manages the activities for all Alexion REMS Program across the ... management of key risk management vendors as needed. The Senior Manager plays a pivotal role in...programs and is responsible for proper documentation of the process through the creation of Standard Operating Procedures (SOPs)… more
    Ivy Exec (05/15/18)
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  • Sarepta Therapeutics, Inc. (Cambridge, MA)
    …manuscripts, posters and oral presentations Contribute to standardization and process improvement efforts for Biostatistics function and contribute to ... cross-functional process improvement efforts Education and Skills Requirements: D. in statistics or related discipline with at least three years of experience in the… more
    Ivy Exec (06/02/18)
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  • Alnylam Pharmaceuticals (Cambridge, MA)
    …collaboration skills to partner with Clinical Development, Regulatory Affairs, Pharmacovigilance , Legal, Finance, Business Planning Program Management and other ... pools to minimize risk and maximize value. Manage an efficient supplier selection process driving the team towards a timely decision with all risks identified.… more
    Ivy Exec (05/23/18)
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  • Covance, Inc. a division of LabCorp(R) (Princeton, NJ)
    …resource issues, inclusive of the Drug Safety Project Managers (DSPM) as well as Senior Drug Safety Associates SR. DSA across the DDSSA group. - Manage 'Client' or ... (DDSS&A) operations associated with products including the entire adverse events process : which may include safety data collected from clinical trials and/or… more
    HireLifeScience.com (07/06/18)
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  • Merck USA (Upper Gwynedd, PA)
    …the CSRM organization and a member of the Global Clinical Safety & Pharmacovigilance Senior Leadership Team. The incumbent will partner and collaborate closely ... Demonstrated ability to work effectively across functions and divisions and influence process and decisions at a senior management level Demonstrated ability to… more
    Merck (06/04/18)
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  • ZS Associates (Princeton, NJ)
    As a Business Consulting Manager , you will: Responsibilities: Have a significant direct client interaction, managing multiple projects simultaneously; Apply advanced ... with key business decision makers that drive new business development; Update senior leaders, prepare and present client presentations Manage and advise the clinical… more
    Ivy Exec (06/12/18)
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  • ZS Associates (Princeton, NJ)
    …Area supporting our Technology and Platform services across multiple clients. MANAGER ZS Managers manage overall projects and client engagements. They support ... and efficiency in their research operations. As a Business Consulting Manager , you will: Responsibilities: Have a significant direct client interaction, managing… more
    ZS Associates (05/15/18)
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  • Astellas (Northbrook, IL)
    …labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the ... process . This position will have global responsibility, providing oversight...effect decisions with local and global team members (eg, Pharmacovigilance , Medical Affairs, and affiliates members). The position reports… more
    Ivy Exec (07/05/18)
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