Manager, Pv Compliance And Quality

5+ years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Functional Area Description

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. This group oversees pharmacovigilance and pharmaco-epidemiology deliverables, including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, 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 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. Contribute to the development of efficient and effective Quality Monitoring (QM) programs and processes as well as 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.
Conduct quality and compliance monitoring activities concerning safety signals, key medical safety information such as safety information in product labels, Individual Case Safety Reports (ICSRs), and other relevant areas of pharmacovigilance.
Collaborate with local and global Quality oversight leads, Case Management, and Medical Review Teams for continuous quality improvement.
Communicate suggestions on revising quality monitoring strategies and programs based on results, business risk, and feedback.
Ensure effective communication to local Quality oversight leads regarding identified risks and recommendations for quality improvement.
Execute quality monitoring activities associated with the 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 to review their performance metrics and ensure compliance with contractual and regulatory requirements.
Escalate any suspected compliance or quality concerns related to in-house or outsourced Pharmacovigilance activities to management.
Provide support to the WWPS organization for maintaining quality and compliance standards.
Suggest process improvements based on identified issues to enhance the effectiveness and efficiency of the WWPS organization.
Assist in developing and maintaining the PV compliance tool, including IT project management, configuration workshops, and User Acceptance Testing.
Maintain in-depth knowledge of global pharmacovigilance regulations impacting the research, development, and marketing of medicines and devices.

Degree Requirements

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

A minimum of 5 years of 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 JIRA management, HP ALM, and SharePoint management, is preferred.
Strong scientific background in a life science-related field.
Prior quality-related experience in pharmacovigilance is preferred.
Proven ability to negotiate compliance issues and work in a complex, changing environment.

Key Competency Requirements

Operational Skills:

Technical Proficiency: Experienced in advanced functionalities of operational tools and integrates digital automation tools into daily workflows.
Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
Process Management: Optimizes existing processes through incremental improvements and digital enhancements.

Analytical Skills:

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

Strategic Skills:

Strategic Thinking: Understands the role of 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.
Demonstrates the ability to analyze and interpret complex regulations.
Possesses excellent communication skills for conveying quality improvement recommendations.
Proficient in Microsoft Office Suite, Spotfire, JIRA, SharePoint management, HP ALM, Corporate Safety Database, ARIS-G, and web-based employee time tracking.

If you come across a role that intrigues you but doesn’t perfectly align 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™,” 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. 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 determining where employees are required to conduct their work, including site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type is determined by the role’s nature and responsibilities:

Site-essential roles require 100% onsite presence.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite presence.
Field-based and remote-by-design roles require physical travel to visit customers, patients, or business partners and attend meetings.

BMS is committed to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Applicants can request accommodations during the recruitment process. If you need reasonable accommodations, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

BMS cares about the well-being of our staff, customers, patients, and communities. As a result, the company strongly recommends all employees be fully vaccinated for Covid-19 and stay updated with Covid-19 boosters.

BMS will consider qualified applicants with arrest and conviction records for employment, pursuant to applicable laws.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.