Safety Risk Management Director, Open to flexible working

5 days left

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
25 Nov 2021
Closes
08 Dec 2021
Ref
313658
Contract Type
Permanent

Are you energised by the challenge of defining the company strategy for Safety Risk Management for an entire CH portfolio? If so, this role of Safety Risk Management Director could be an exciting opportunity to consider.

As Safety Risk Management Director, you will be responsible for driving excellence in process design and efficiency, creating value by integrating, standardizing and sustaining safety risk management in a risk-proportionate way for the entire CH portfolio and in accordance with regulatory requirements and industry standards. You’ll be responsible for the end-to-end process of scheduling, production and submission of Safety Risk Management Plans and other benefit-risk assessments. You will have accountability for establishing and maintaining a framework for product safety risk management and maintaining close oversight on implementation of risk minimisation strategies at the country level. 

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Design, develop and implement a streamlined process for safety risk management plans to fulfil specific country requirements
  • Ensure that strategy in managing safety concerns is proportionate to safety risks of CH products (e.g. medicinal products, devices, cosmetics, nutritionals)
  • Support cross-functional teams in elaborating safety risk management strategies and delivering required documentation of high quality
  • Drive development of benefit-risk assessment and selection of tools to minimize risks while maximizing benefit to the patient
  • Provide safety input and oversight to studies involving all product types, including clinical studies, real-word evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies
  • Maintain and enhance Umbrella Brand Name Evaluation framework and act as a safety advisor for concerned innovation project teams
  • Influence the external environment representing the company at meetings with regulatory authorities, industry groups and/or vendors to shape development of innovative methodologies
  • Build a strong network of stakeholders across the company (e.g. Regulatory, Medical, Clinical, New Product Development, Consumer Science and Product Understanding) to ensure successful implementation of the safety risk management strategy
  • Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards pertaining to safety risk management
  • Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection and provide expert advice on responses to audit observations; be point of contact and interact with inspectors to support audits as appropriate.

APPLICATION CLOSING DATE – 8th DECEMBER 2021

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Degree in Biomedical or Healthcare-related speciality (ideally advanced life-sciences degree)
  • In-depth Pharmacovigilance and process knowledge
  • Expert evaluation skills and analytical thinking
  • Experience in clinical development and real-world evidence programs
  • Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to risk management of different product types
  • Expertise in risk minimisation methodology and management of its effectiveness 
  • In depth knowledge of medical and drug terminology and a sound foundation in pharmacology

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Ability to lead tasks, projects and processes across a large organisation
  • Highly effective communication skills; ability to present complex data to groups at all levels of the organisation and external to the company
  • Excellent leadership skills in a matrix team setting
  • Highly developed negotiation and influencing skills
  • Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
  • Ability to adjust behaviours and priorities based on changing environment
  • Demonstrated ability to think tactically and strategically, and take account of internal/external environment when considering safety issues and business processes

Why Consumer Healthcare?

Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

Diversity, Equity and Inclusion

In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers.  As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.  Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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