Product Vigilance Manager

at  British American Tobacco

EXPERIENCE REQUIRED

• Strong relevant experience – Product Vigilance, Pharmacovigilance or similar
• Strong understanding of safety surveillance, Adverse Event management and consumer complaint/spontaneous reporting
• Excellent knowledge of MedDRA coding dictionary
• Familiarity with FDA, EMA, Health Canada, and international adverse event reporting regulations per ICH guidelines
• Can demonstrate experience in project management and management of diverse partner groups

TECHNICAL / FUNCTIONAL / LEADERSHIP SKILLS REQUIRED

• Must be quality orientated and demonstrate consistent attention to detail
• Excellent communicator - both written and verbal
• A strong planner who is effective in prioritisation and organisation
• Proficient in partner management
• Comfortable leading complex discussions and negotiations, maintaining a professional and positive stance
• Ability to lead intricate and technical projects
• Leads by example, is collaborative, with the ability to engage with cross-functional teams and partners
• Accountable, with an attitude that ensures project delivery OTIF, in line with an overarching vision

EDUCATION / QUALIFICATIONS / CERTIFICATIONS REQUIRED

• BSc in a life science related field
• Demostrable EU/FDA Pharmacovigilance experience

WHAT ARE THE KEY OBJECTIVES AND EXPECTATIONS FROM THIS ROLE?

As the Product Vigilance Project Manager, you will be an ambassador for Product Vigilance working across the BAT Group, constantly focussed upon ensuring agreed programme improvements, requirements and extensions are delivered on time, in full and with the vital internal business alignments, in accordance with the Global Product Vigilance vision and with safety regulatory requirements applicable to BAT’s New Categories and Beyond Nicotine portfolio.
You will work closely with the Global Product Vigilance Manager, to deliver each of the programme expansion phases, keeping to the forefront the key objective of strengthening the all-encompassing safety data associated with each new product category, to support internal and external needs.

WHAT IS THE DIRECT IMPACT OF THIS ROLE ON THE TEAM OR ORGANIZATION?

This is a fundamental role for owning the core projects vital, in the expansion of the Product Vigilance Programme at BAT, all with the ultimate goal of elevating our safety surveillance and reinforcing a robust repository of safety data, to support the business and business dedication, to tobacco harm reduction.

WHAT YOU WILL BE ACCOUNTABLE FOR

• Build and maintain sufficient knowledge of EMA, US & Japanese pharmacovigilance regulations and Good Vigilance Practices, to support BAT’s proactive approach in the delivery of enhanced vigilance practices and to support the fulfilment of mandatory Product Vigilance requirements of our Natural Health Product portfolio.
• Develop and maintain a strong connection with BAT’s Adverse Event case management processes and all core safety surveillance processes, to ensure all programme extensions consistently connect to the vigilance system which is the heartbeat of the Product Vigilance department and can also consider vital system extensions.
• Focus upon data integrity and accuracy in every workstream, always ensuring that legacy data and new data is 100% accounted for
• Approach all integration projects and core initiatives in accordance with formal project management principles and procedures, including but not limited to, a scoping, discovery, kick off, execution, launch and Post Implementation Review phases.
• Craft and develop all integration projects in accordance with the Product Vigilance Master File, (developing this with the Global Product Vigilance Manager as vital, being responsible for the suitability of the project amongst the broader vigilance system, so that all processes work in conjunction and feed into or surround one central and secure vigilance repository.
• Own the planning and documentation with the relevant internal SMEs and Product Vigilance Team of the full suite of documentation, vital to support the operationalising of all new integrations.
• Support the Product Vigilance Programme Lead, to forecast the future programme evolution, particularly taking ownership for intelligence around upcoming ‘beyond nicotine; pipeline launches and new category product development whereby the recipe and sensorial profile is adjusted.

CAN THIS BE YOUR FUTURE ROLE?

• Do you have experience of pharmacovigilance, if yes to what extent?
• What is your vendor management experience?
• Are you proficient in consumer complaint/spontaneous reporting?

At BAT we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at BAT.

• Global Top Employer with 53,000 BAT people across more than 180 markets
• Brands sold in over 200 markets, made in 44 factories in 42 countries
• Newly established Tech Hubs building world-class capabilities for innovation in 4 strategic locations
• Diversity leader in the Financial Times and International Women’s Day Best Practice winner
• Seal Award winner – one of 50 most sustainable companie