Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Global Quality, Clinical Trials & Safety is responsible for auditing all processes related to clinical research and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator sites, internal systems and external vendor audits. GQ CT&S is also responsible for the management of regulatory agency inspections and for providing advice on regulatory requirements.
The candidate will be responsible for:
• Performing Pharmacovigilance audits, including audits of critical processes, affiliates, service providers/vendors and licensing partners to assess regulatory compliance, through:
- Applying audit principles, procedures, and methods to prioritize and focus on matters of significance;
- Collecting information through effective interviewing, listening, observing and reviewing documents, records and data;
- Evaluating independently and critically the quality management system and operations, balancing weaknesses against requirements and expectations;
- Confirming the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
- Assessing those factors that may affect the reliability of the audit findings and conclusions;
- Performing and documenting analyses of audit findings where indicated:
- Preparing clearly-written, concise, accurate and evidence-based audit report;
- Maintaining the audit management database;
- Reviewing and assessing corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
• Participating in the preparation, hosting and follow-up of regulatory authority inspections related to clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors;
• Participating in due diligence activities and qualification audits of potential new vendors/partners;
• Maintaining an in-depth knowledge of Clinical Safety and PV system regulations as they apply throughout a product’s life-cycle;
• Providing advice and counsel concerning GVP regulatory requirements;
• Mentoring of new GQ-CT&S staff, as required.
Requirements:
• University graduate, Life Sciences degree preferred;
• In-depth knowledge of Clinical Safety and PV systems in the pharmaceutical industry and of applicable regulations. Able to apply theoretical knowledge in practical situation;
• Minimum of 4 years of experience in Pharmacovigilance gained from the pharmaceutical industry or equivalent;
• Minimum of 2 years technical PV auditing experience or equivalent;
• Demonstrates computer literacy and is able to function independently within an environment that relies heavily on technology for information and communication;
• Thorough understanding of the drug development and marketing processes;
• Excellent oral and written communication.
• Fluent in English, any other languages are a plus
• Sense of diplomacy and discretion;
• Maintains the confidentiality and security of information, data, documents and records;
• Demonstrates commitment to delivering a high-quality work product;
• Knowledge of relevant BMS policies and consequences of using sampling techniques for auditing;
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
• Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
• Develops strong working relationships with key stakeholders;
• Ability to manage competing priorities.
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 the resources to pursue their goals, both at work and in their personal lives.
