Manager, PV Compliance and Quality

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. Ensure ongoing regulatory compliance and mitigation of potential risks associated with PV activities delivered by WWPS.

Contributes to the development of efficient and effective Quality Monitoring (QM) programs and processes as well as the PV compliance tools and dashboards that support the QM programs.

Position Responsibilities

Perform ongoing monitoring of end-to-end case processing related activities in the global safety database.

Perform quality and compliance monitoring activities with respect to safety signals, key medical safety information such as safety information in product labels, Individual Case Safety Reports (ICSRs), and other relevant areas of pharmacovigilance in support of a strong GVP Quality Management System.

Collaborate with local and global Quality oversight leads, Case Management and Medical Review Teams for continuous quality improvement by ongoing communications regarding any quality trends and reinforcement of process.

When applicable, communicate suggestions on revising quality monitoring strategies and programs based on results, business risk, external and/or internal feedback.

Ensure effective communication to local Quality oversight lead regarding the identified risks and recommendations for the potential improvement of quality.

Execute quality monitoring activities associated with measure of effectiveness of health authority, audit, or Deviation CAPA implementation to ensure improvement and fulfillment of BMS’ agency obligations.

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 to management.

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.

Provide suggestions on process improvements based on identified issues to Local Quality lead for the management of PV Compliance and Risk Management organization to increase the effectiveness and efficiency of the WWPS organization.

Assist in development and maintenance of the PV compliance tool which includes but not limited to IT Project management, participate in configuration workshops, and User Acceptance Testing.

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.

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

Degree in healthcare science such as 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 5 years pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience specifically involving Safety Database case processing.

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 quality related experience in pharmacovigilance preferred.

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

Operational Skills:

Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilizes digital automations tools into daily workflows. Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods. Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.

Analytical Skills:

Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data. Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments. Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.

Strategic Skills:

Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies. Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines Change Management: Supports digital change initiatives and communicates their immediate benefits.

Advocates the highest standards of quality and compliance.

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, ARIS-G preferred

Web-based employee time tracking

Uniquely Interesting Work, Life-changing Careers
With 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 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 . Visit 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.

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