Director, Safety and Pharmacovigilance ViiV

ViiV Healthcare is an independent, global specialist HIV company that is committed to delivering innovative new options for the care and treatment of people living with HIV/AIDS. ViiV is 100% dedicated to HIV medicines and research, and completely focused on people affected by HIV/AIDS, leaving no patients behind. The ViiV Global Safety team partners closely with GSK Safety teams in managing the safety profile of ViiV Healthcare portfolio, spanning early development asset to marketed medicines.

Are you an advanced safety/pharmacovigilance professional (physician and/or scientist) with in-depth experience in managing safety of assets in development as well as marketed products?

Reporting directly to the Vice President (VP) Head of Safety and Pharmacovigilance within ViiV Healthcare, the Director of Safety and PV as a member of a global team will be responsible for overseeing components of ViiV PV quality management system, and safety activities including signal detection, safety evaluation and risk management activities conducted by GSK safety team, for all ViiV portfolio.

The individual will lead projects and must demonstrate agility, ability to prioritize, and capability to function at a high level with cross-functional leaders at both GSK and ViiV. This person must be experienced at working in a matrix environment to advance the safety and biological understanding of ViiV portfolio throughout the life cycle. The individual who assumes this position will interact with multiple levels of management within GSK and ViiV and with external stakeholders and is expected to be able to influence the strategic direction of complex issues for the assigned portfolio.

The role has a global remit and key responsibilities are as follows.

Key responsibilities of the role include:

• Supporting Head of Safety in providing senior level oversight into monitoring the safety and benefit/risk profile of ViiV portfolio, as well as overseeing performance of ViiV PV system spanning case processing activities, safety evaluation and risk management activities

• Partnering with GSK safety teams and ViiV clinical and non-clinical teams, provide strategic input into safety aspects of clinical trials, interpretation of safety data for delegated assets in development,

• Providing strategic input into ViiV paediatric programmes, including interaction with external partners and responsible for senior level sign off for submission documents including responses to questions from regulatory authorities

• Working with GSK safety teams provide strategic direction to safety evaluation and risk management activities for assigned assets and products

• Endorsement and senior sign off for delegated activities/documents

• Attending ViiV Safety and Labelling governance meetings and provide safety expertise to Chief Medical Officer in their decision making related to patient safety, product benefit-risk and labelling discussions. Provide direction to teams presenting information to VSLC to ensure completeness of information for decision making and may be sponsoring teams presenting on assigned assets/products

• Attending QPPV office and Oversight Committee meetings, supporting Head of Safety and QPPV with active engagement in ensuring oversight of performance of ViiV PV system

• Managing ViiV-GSK account meetings to assure PV services provided meet needs of ViiV PV system

• Attending the relevant ViiV governance meetings responsible for review of proposed Investigator Supported Studies and provide Safety direction to safety aspects of studies

• Attending signal management meetings coordinated by GSK Safety team and provide oversight of signal management activities for assigned products

• Deputising for Head Safety and PV, where and when needed

• Leading projects/initiatives to advance science of safety and PV impacting ViiV portfolio and improve ViiV Quality Management System

• Supporting creation, updates and improvements of ViiV PV processes

• May function as advisor to ViiV teams on activities which may involve generation of safety data

• May function as a line manager for safety staff

Why you?

Basic Qualifications:

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

• Medical Degree (i.e. clinician/physician/medical practitioner) and/or PhD or equivalent advanced medical sciences education, from an accredited reputable University.

• Significant relevant pharmaceutical industry experience with a successful track record in all aspects of safety and PV activities.

• Additional experience in Pharmaceutical Medicine outside of Pharmacovigilance (Drug Discovery, Drug Development, Medical Affairs, Medical Information) will be an asset

• Must have a strong understanding of FDA, EMA and other Health Agency regulations regarding post-marketing surveillance

• Extensive knowledge and understanding of PV deliverables, standards and processes at a global level

• Ability to navigate across a matrixed environment

• Excellent written and oral communication skills

• Strong scientific acumen and the ability to work in a dynamic matrixed environment are key traits for an individual in this role

Interested in Joining the Team?

Please apply via our online portal providing your CV and Cover Letter.
(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)

#LI-GSK

Closing Date: 18th April 2023

While our currently location is Brentford, NW London, We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A by end H1 2024.

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 38 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.

Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we’re all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

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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ViiV Healthcare does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV Healthcare's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV Healthcare. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV Healthcare. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV Healthcare. ViiV Healthcare shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.