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Job Title:  Product Vigilance Manager

Job Number:  29636

Country: United Kingdom
Location:
Southampton
Function: Scientific Research & Development
Level: Experienced Professional
Appointment Type: Permanent

 

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!

BAT UK IS LOOKING FOR A PRODUCT VIGILANCE MANAGER

SENIORITY LEVEL: Junior Level

FUNCTION: Scientific Research & Development (R&D)

LOCATION: Southampton

 

ROLE POSITIONING AND OBJECTIVES

This role is part of Scientific Research & Development - Potentially Reduced Risk Product Science    

The role is responsible for enhancing and developing safety Product Vigilance (PV) infrastructure to current and next generation consumer products, ensuring compliance with UK and international PV regulations, and quality is maintained and issues are escalated appropriately and resolved, occupying role of point-of-contact for PV activities from consumer reporting to the R&D team and to creating efficiencies within PV process, identifying and providing guidance to implement process improvement updates, leading audits and analysis of PV results for internal meetings, to author PV documentation and data presentation to external global regulatory bodies, regulatory reports, contributing to safety sections of clinical investigator brochures, risk profiles, protocols, labels, providing/ implementing proactive safety analysis strategies to further define the product safety profile, supporting the development and validation of PV across 3rd party CROs, supporting and driving the delivery of PV and safety assessment across multiple R&D technical projects, providing relevant cross-function PV training across the corporate ecosystem where necessary.

 

Reports to: Chief Medical Officer (CMO)

Reporting Level: Individual Contributor

Geographic Scope: Global

 

WHAT YOU WILL BE ACCOUNTABLE FOR

  • Provide PV input (of established international standards) into activities associated with adverse events from clinical trials and post-marketing adverse events
  • Applies PV knowledge to operationalize strategic priorities, safety governance process improvements, and operating procedures to ensure compliance with appropriate regulations and quality standards for consumer products for pre-approval and post-marketing.
  • Manages on-going product safety in support of the safety governance process
  • Participates in company safety boards
  • Approach to task is by selection of appropriate means learned from knowledge and experience and thorough understanding of principles and concepts
  • To develop and apply new and existing methods for the analysis of product vigilance (PV) data order to provide direction and to set the strategy across the team
  • Sets the strategy/direction for 'Best Practice' (e.g. FDA, MHRA, EMA, ICH)
  • Ensure that case processing activities are being completed accurately as per regulatory requirements

 

CAN THIS BE YOUR FUTURE ROLE?

  • Have you worked in pharmacovigilance, consumer product vigilance?
  • Have you submitted vigilance documentation to regulatory authorities?
  • Are you familiar with data integration and homogenisation of vigilance datasets?

 

ESSENTIAL EXPERIENCE, SKILLS AND KNOWLEDGE

  • In depth PV experience from consumer healthcare or pharmacological backgrounds (five years or more)
  • Experience in regulatory authority inspections (MHRA, EMA, FDA)
  • Expert in Good Vigilance Practice and operating and maintaining a product vigilance system
  • Expertise in handling a range of healthcare products (including medicines, medical devices, cosmetics, food supplements)
  • Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters with internal staff and external authorities
  • Excellent communication and collaboration skills with the ability to present to internal/external groups and establish and maintain good working relationships with a diverse population
  • Detail-oriented, with good organizational, prioritization, communication, and time management proficiencies
  • MSc or PhD, with proven experience or background in PV (pharmacovigilance) and data analysis

 

BENEFICIAL

  • Experience in integrating and interpreting multiple datasets
  • Expert in the use of data visualization tools to communicate to stakeholders at various levels, including those with scientific and non-scientific backgrounds
  • Bonus target up to 25% of annual base salary
  • 25 days annual leave
  • Participation in Discretionary Company Bonus Scheme
  • Participation in Company Share Reward Scheme
  • Company Pension Scheme
  • Private Healthcare Cover
  • Eligibility for Company Flexible Benefits Scheme

 

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!

 

British American Tobacco is one of the world’s leading multinational companies, with brands sold in over 200 markets, made in 44 factories in 42 countries.

We are proud that we are consistently among the top 5 companies on the London Stock Exchange.

Our portfolio includes our world-famous Global Drive Brands – Dunhill, Kent, Lucky Strike, Pall Mall and Rothmans – along with many other leading international brands, such as Vogue, Peter Stuyvesant and State Express 555.

Alongside our traditional tobacco business, we are also developing products that offer consumers potentially less risky alternatives to regular cigarettes. Our Next Generation Products are already leading the way in the Industry of vapour and tobacco heating devices. We continue to develop a solid portfolio of consumer solutions which already include well known global brands like Vype, glo and Voke.

Contractual Legal Entity: BAT (Investments) Limited (GBIN)


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