Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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careers.Bms.Com/working-with-us The PV and LifecycleManagementQuality pillar in Research & Development Quality (RDQ) provides independent quality oversight on the clinical safety/PV, RA and MA qualitymanagement systems applied during the lifecycle of products, managed by global internal and external stakeholders.
Key responsibilities:
Oversee and contribute to the qualitymanagement system relating to Clinical Safety/ Pharmacovigilance, Regulatory and Medical Affairs activities, throughout the product lifecycle; Manage critical and/or complex quality issues in the PV & LCM Quality remitAct as an expert and advise on regulatory, clinical safety/ pharmacovigilance related mattersEstablish partnership with business stakeholder.Oversee and contribute to the qualitymanagement system in support of Patient Safety, Regulatory, Medical Affairs and Commercial activities throughout the product lifecycleIntegrate end –to end quality principles.Establish partnership with business stakeholderPresent key data (compliance, conformance, issues and risks) to drive decision makingAct as an expert and advise on clinical safety/ pharmacovigilance related matters:
Provide guidance and training on relevant GxP regulations and guidelines to cross functional business partners.Manage critical and/or complex quality issues in the PV & LCM Quality remitEngage in appropriate activities to support and manage Health Authority PV inspections OtherLead or contribute to multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/disciplineLead or contribute to the implementation of large-scale initiatives and/or organizational changes (functional optimization) that affect the departmentAct as a credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the line or cross-linesDrive quality into the business through proactive quality support, mentoring and/or coaching and consultation.Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional levelProvide input in the global audit plans based on identified signals/trends/risks/gapsInfluence the external environment through interactions with regulators, trade associations, or professional societiesShare knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systemsResponsible for training and providing performance feedback for less experienced staff Key Stakeholders/ContactsInteraction with peers in R&D Quality, Global Quality and GPSInteraction within R&D, incl.
Worldwide Patient Safety, Regulatory Affairs, Medical Affairs, Commercial, in relation to PV audits, CAPA and PV training; External engagement as agreed with industry/trade/QA associations, and pharmaceutical company peers; Internal engagement as needed with relevant R&D partners and corporate functions Key requirements:
University Graduate in Pharmacy, Medicine or Life Sciences.Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities.
Quality Assurance/Compliance and PV /Regulatory Affairs auditing experience preferred or equivalent combination of education, training and experience in Pharmacovigilance.Strong experience in the pharmaceutical industry or equivalent.Clinical, Medical, Pharmacovigilance or Regulatory QualityExtensive experience in Pharmacovigilance/Regulatory Affairs.
Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education, training and experience in Pharmacovigilance.
Competencies – knowledge, skills and abilitiesDemonstrated strong knowledge of global PV legislation and guidance, ICH/GCP, clinical research, medical affairs and regulatory processes and principles of Quality AssuranceUnderstanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)Broad knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk managementProficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with dataProject Management:
Must be able to manage projects and deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines SoftwareMicrosoft SuiteVeeva Vault QMSSharePointOther systems as assigned/applicable Additional InformationUp to 25% travel to perform audits.Up to 5 overnight absences per month #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
Visit careers.Bms.Com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
BristolMyersSquibb is Disability Confident – CommittedA UK Government scheme BristolMyersSquibb BoudryNeuchâtel
