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Date Modified

April-2024

HR Job Title

Sr Manager, PV Compliance and Quality

Self-Managed Business Role

Division

Research and Development / Global Drug Development

WorldWide Patient Safety/ Compliance, Quality and Learning

PV Compliance and Quality Risk Management

Functional Area Description

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines: WWPS group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

PV Compliance and Quality Risk Management within Compliance, Quality and Learning is accountable for quality, compliance and inspection readiness activities in WWPS through ongoing monitoring of safety outputs in order to ensure compliance and quality excellence with respect to worldwide GVP regulations, guidance, and inspectorate expectations.

Position Summary

Provide Quality oversight through ongoing monitoring of safety outputs created by WWPS to ensure continuous compliance and quality excellence with all applicable safety guidelines and regulations. Provide quality oversight by monitoring key WWPS activities focusing on controls to ensure ongoing regulatory compliance to mitigate potential risks associated with PV activities delivered by WWPS.

Lead, with heads of Quality and Compliance, the collaboration with BMS IT or IT vendors for developing innovative solutions for the advancement of Quality Monitoring (QM) programs using PV Compliance tools and dashboards. Ensure proper control and implementation of business requirement for successful development and maintenance of the PV compliance tool.

Position Responsibilities

Develop, implement and/or coordinate quality and compliance monitoring activities with respect to safety signals, key medical safety information such as product labeling reference safety information section, Individual Case Safety Reports (ICSRs), and other relevant areas of pharmacovigilance in support of a strong GVP Quality Management System.

Lead collaboration with Case Management, International, Safety Scientists, Global Risk Management, and Medical Review Teams for continuous quality improvement by ongoing communications regarding any quality trends and reinforcement of process.

Collaborate with heads of Quality and Compliance to evaluate and revise Quality Monitoring strategies and programs based on results, business risk, external and/or internal feedback.

Manage effective communication to WWPS stakeholders regarding the identified risks and recommendations for the potential improvement of quality in collaboration with HQ PV Compliance designee.

Develop departmental standard operating procedures and training relating to core responsibilities performed at the local BMS site as needed.

Manage quality oversight activities through ongoing monitoring of end-to-end Case processing related activities in Global Safety database.

Maintain in-depth knowledge of global pharmacovigilance regulations that impact the research, development and marketing of medicines and devices as well as relevant Bristol-Myers Squibb Company policies and procedures Within the area of expertise.

Manage and oversees Quality Monitoring related activities associated with the measure of effectiveness of health authority, audit or Deviation CAPA implementation to ensure improvement and fulfillment of BMS\' agency obligations.

Maintain quality monitoring/oversight programs and ensure ongoing management of key PV compliance and quality monitoring activities at the local BMS site.

Ensure effective communication with key WWPS stakeholders and vendors (where applicable) to include review of their performance metrics ensuring the expectations are met and that delegated functions are performed in accordance with contractual and regulatory requirements.

Escalate any suspected compliance, quality concerns or potential risks associated with in house OR outsourced Pharmacovigilance activities. Plans remediation actions in collaboration with HQ PV compliance designee and respective stakeholders where compliance expectations fail to meet minimum thresholds.

As part of a high-performance team, help to provide support to the WWPS organization for the purpose of maintaining a standard of quality and compliance with existing global regulations, compliance requirements and internal policies and procedures.

Partner with management of PV Compliance and Risk Management organization to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS organization.

Develop and maintain the PV compliance tool related activities that includes but not limited to IT Project management, participating configuration workshops and cascading these learnings to team members at BMS local site, assists in finalize system requirements, requirement implementation plans, User Acceptance Testing, develop training to PV compliance and relevant audience at BMS local site and assurance of the system compliance with regulatory requirements.

Degree Requirements
Required degrees, certifications, and/or licensure relevant to role.

Degree in healthcare science B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.

Experience Requirements
Minimum number of years of relevant experience expected.

A minimum of 8-10 years pharmaceutical industry experience, including 7 years of pharmacovigilance, drug development, clinical development, or regulatory affairs experience. PV Compliance and quality monitoring related experience is preferred.

Proven ability to motivate and challenge a high performing team to maximize the effectiveness of the Quality Monitoring Programs.

Prior experience in IT project management including the skills for JIRA management, HP ALM, and share point management is preferred.

Strong scientific background in a life science related field

Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance.

Successful and creative negotiation of difficult compliance issues.

Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.

Key Competency Requirements

Advocates the highest standards of quality and compliance while employing innovative techniques and tools.

Maintains awareness of evolving regulatory, and company compliance requirements including directives, policies and procedures related to Global Pharmacovigilance activities.

Demonstrates ability to analyze and interpret complex regulations to determine impact on company operations and policies and in developing action plans to optimize compliance.

Possesses excellent communication skills which are used to convey recommendations for quality improvements to our internal and external customers.

Demonstrates effective oral/written communication and strong interpersonal relationship skills.

Microsoft Office Suite, Spotfire or any other visualization tool skill set, JIRA, SharePoint management, HP ALM.

Corporate Safety Database

Web-based employee time tracking

Document management system for authoring, reviewing and approving electronic documentation (i.e., SharePoint, etc.) Corporate learning management system

Travel Required (nature and frequency).

Approximately 5-10% travel, including overnight may be required, including other BMS sites, or business partners/CROs to assist in various quality or inspection related activities; attend professional meetings and seminars.

Describe exposure to any hazards/disagreeable conditions in the work environment

This position is office based: N/A

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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 Careers
With a single vision as inspiring as Transforming patients\' lives through science\xe2\x84\xa2 , 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 Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

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