Product Vigilance Specialist

BAT is evolving at pace - truly like no other organisation.

To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!

SENIORITY LEVEL:Junior level

FUNCTION: Scientific Research & Development

SUB FUNCTION:Global Life Sciences (GLS)

LOCATION:Southampton, UK

TYPE OF CONTRACT:Permanent

BENEFITS

• UK yearly Incentive Bonus – competitive % based on business results and average annual salary
• Attractive Private Pension Plan - up to 15%, Private Medical cover, Doctor @hand-24/7 GP appointments, by video or by phone, 365 days a year, from anywhere in the world
• Share Reward Scheme (free shares and share saving scheme), Group Personal Accident Insurance, Life Assurance
• Flexible Benefits Scheme: Tax Return Assistance, Cycle To Work, Holiday Trading, Dental Insurance, Travel Insurance; Onsite Gym and Gyms Discounts-discounts at over 3,700 gyms, SPAs, pools, studios and outdoor fitness events across the UK; Season Ticket loans-Interest free loans for purchase of annual tickets for public transport

What are the key objectives and expectations from this role?

• To fulfil a critical role within the Global PV-PMS team focussed upon product vigilance. The Product Vigilance Specialist will support the Product Vigilance Manager by working as key SME and POC for the global safety database, with the primary objective of ensuring the database is continuously monitored, up to date and can support necessary data requests and submissions
• The expectation is that this role will be accountable for the handling of cases from multiple sources within the safety database, from receipt through to closure
• The role requires the ability to organise, assess and understand the trends in Product Vigilance (PV) data and work collaboratively with a group of cross functional SMEs and end market teams, across multiple workstreams surrounding the safety database

What is the direct impact of this role on the team or organisation?

• This role is part of the Global Life Sciences (GLS) sub-function. The role of GLS is to lead and drive the science programme to provide the scientific evidence to demonstrate the reduced risk status for BAT’s products in support of tobacco harm reduction, regulatory acceptance, and consumer claims. This is achieved through a weight of evidence approach to support scientific publications, internal company positions, external product claims and regulatory submissions.

WHAT YOU WILL BE ACCOUNTABLE FOR

• Receiving, processing, handling and recording spontaneous safety cases reported to the business, ensuing accurate coding and the relevant and necessary assessment
• Continuous maintenance of the core product vigilance database and management of the administrative activities involved with the running, audits and due diligences fundamental in ensuring constant global regulatory compliance
• Ownership and continuous maintenance of the PV terms list used by a number of markets and business areas, to support safety data reporting globally
• Support in the creation and deployment of training associated with the correct reporting to and use of the safety database, to teams across the BAT group
• Key POC for clinical and consumer research study teams in relation to safety data, the processes, case coding and assessments
• Contribution to the fulfilment of processes relating to signal management
• Support in the generation of necessary data required for the development of internal and external reports, on both an ad hoc and cycle basis
• Identification of enhancements and efficiencies which can be considered for continuous improvement of the day-to-day case processing cycle
• Support with the maintenance of cumulative safety data received from sources including literature, media, academic journals and publications and national regulatory authorities

CAN THIS BE YOUR FUTUE ROLE?

• Do you have experience of pharmacovigilance, if yes, to what extent?
• Which type of large datasets have you previously been accountable for?
• Do you have experience working with external vendors?
• Would you be willing to complete a number of courses in order to build your PV knowledge, based upon your level of experience?

ESSENTIAL EXPERIENCE, SKILLS, AND KNOWLEDGE

Experience Desired

• Product vigilance or post market safety surveillance in the consumer healthcare or pharma industries
• Maintenance of a pharmacovigilance system or similar
• Understands and demonstrates use of MedDRA coding and working to good vigilance practices (GVP)
• Financial and business awareness, with experience of dealing with third party vendors and regulatory authorities
• Awareness of FDA requirements within pharmacovigilance

Technical / Functional / Leadership Skills Desired

• Excellent communicator, both written and verbal
• Professional, proactive and positive stance
• Diligent, organised, with a high regard for attention to detail
• Ability to handle large amounts of data and generate creative solutions and analysis
• Collaborative, with the ability to engage with cross-functional teams and stakeholders
• Can work effectively as part of a cross-functional team or autonomously
• A quick and enthusiastic learner
• Remains calm with a consistent persona during challenging circumstances

Education / Qualifications / Certifications Desired

• Education to degree level or above
• Pharmacovigilance or medical background
• Fluent in written and spoken English

WE ARE BAT

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 companies

BELONGING, ACHIEVING, TOGETHER

Collaboration, diversity and teamwork underpin everything we do here at BAT. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!