Director, Pharmacovigilance PV Operations, Obesity US, Remote
1 month ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Director, Pharmacovigilance PV Operations, Obesity US, Remote
Live
What you will do
Lets do this. Lets change the world. In this vital role you will Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Responsible for overseeing the processing and submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Oversee all interactions with business partners (license partners) and vendors for all case intake and processing activities. Oversee vendor oversight of all intake case processing for adverse events, and intake/triage of product complaints, including analysis and reporting of trends in quality measures for rare disease portfolio. Ensure vendor compliance with approved processes and training requirements. Provide audit and inspection support.
Job Summary:
Act as business process owner (BPO) and point of contact AE Intake processes including training, controlled documents and systems for MariTide platform and for Rare Disease portfolioProvide Safety Intake expertise for Data Element Standards Committee relating to development and delivery of compliant eCRF/CRFs that facilitate accurate and complete clinical trial SAE data and post market AE data are collected in line with global regulatory requirementsEnsure all Amgen BP/LP PVAs are in compliance with global safety legislation and requirements and meet all case managementOversee relationship between business partners (external) and PSAM (internal) to ensure capture of all adverse event data generated under PVAs.Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessICMC point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Key Activities: Lead and drive ICMC subject matter expertise for eSAE GovernanceEvaluate and implement process improvement strategies for ICMCOwn process content, deliverables/outputs, and metrics (i.e. performance, business, and compliance metrics)Manage communications within the ICMC/PV Operations department training programs; participates in development and modification of procedures and training materialDrive audit CAPAs and other actions/recommendations for and compliance issues are completed documentsAccountable as liaison between clinical trial and Global Patient Safety to ensure capture of all adverse event data generated by such programsResponsible for developing and supporting strong cross-functional relationships and communicationDevelop and communicate plans/objectives to others as neededMaintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methodsLead/Support the implementation of new eSAE processes and methods within and across Global Patient Safety and Global Development OperationsDevelop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicableUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibilityPerforms other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Knowledge and Skills: Able to effectively represent ideas both verbally and in writingExpert knowledge of the global safety environment, regulations and guidanceProject and/or Process Management experience & knowledgeExpert understanding of safety data capture, representation and interpretationExpert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discoveryAble to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionallyAble to organize, plan, and prioritize workload for the functionWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The Drug Safety professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Masters degree and 8 years of Drug Safety or Life Sciences experience OR Bachelors degree and 10 years of Drug Safety or Life Sciences experience In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications:BS, MPH, RN, HCP, or Life Science with years of directly relevant experience (including 6 years of experience in Drug Safety)Experience in leading and managing teamsThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $180,145. to $215,889. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.-
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