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Location

Brentford, Greater London | United Kingdom

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Job description

Site Name: UK - London - Brentford, Belgium-Wavre, Home Worker - GBR, Poznan
Posted Date: Feb 29 2024

Associate Director – Pharmacovigilance Operations

We are seeking a dedicated individual to join our team in the role of Pharmacovigilance Operations Associate Director.

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities:

ICSR Management

• Argus Configuration for new Programs/Studies
• ICSR processing
• Case Processing Coding Conventions
• Local Operating Companies (LOC) Interactions
• Functional Vendor Oversight:
  • New Market Authorisation
  • Withdrawal of Market
  • Authorisation
• Clinical Trial/Program Interactions for:
  • Study/Program Set up
  • Study/ Program Maintenance
  • Study/ Program Close out
• Argus Configuration for Submissions to destinations including:
  • Regulatory Authorities
  • Partners
  • Clinical Research Organisations (CROs)
  • Local Operating Companies (LOCs)
  • Clinical Operations/CROs

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

As a key member of the team, you will be accountable for ensuring adherence to GSK standards and regulatory timelines while driving the implementation of robust processes for successful PV operations activities, including vendor oversight. You will collaborate closely with stakeholders, contribute to problem-solving in a complex matrix environment, and escalate issues as necessary. Your creativity and proactive approach will be essential as you generate new ideas and proposals for global implementation, contributing to the advancement of PV Operations methodology and processes. Additionally, you will ensure that third parties and vendors adhere to quality-driven processes.

In this role you will

• Supervise a team of up to 10 scientific staff (Global/ local) responsible for supporting ICSR Management activities.
• Manage team to ensure appropriate prioritisation and time management, in line with business needs
• Build external relationships with key stakeholders and senior leaders
• Provide project management and case processing oversight for clinical trials and post marketed programs, support spontaneous case processing activities; ensure timely completion of deliverables
• Provide support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations and adherence to GSK SOPs
• Resolve issues and concerns within the ICSR Management team and escalate to ICSR Management Director, where resolution is not possible or there is impact across PV OPS
• Ensure that all ICSR Management activities are appropriately resourced and escalates any resourcing issues
• Provide workload forecasts and work with ICSR Management Director to strategically plan, in line with business goals
• Develop the team, identify training requirements and work with training team to establish required training plan for individuals as required
• Provide strategic advice to the function or oversight of direct and/or indirect reports who perform PV activities).
• Mentor new staff during onboarding
• Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals
• Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams

Why you?

Basic Qualifications & Skills:

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

• Degree in life sciences or medically related field or previous experience equating to educational requirements.
• Line management experience, particularly in a global team
• Experience in and in-depth knowledge of GCP and GVP, CTR, CTD, clinical safety documentation and reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of world-wide regulatory requirements for PV.
• Project management experience
• Ability to map processes and author written standards
• Knowledge and experience with pharmacovigilance systems

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Proven experience developing and delivering high-quality training
• High level of clinical understanding
• Excellent oral and written communication skills
• Proven ability to negotiate and influence stakeholders at upper management level.
• Deep knowledge of principles of data collection, analysis and retrieval and experience summarizing data
• Knowledge of GSK products and awareness of business-unit specific considerations
• In depth understanding of medical and drug terminology
• Experience of escalation mechanisms

Closing Date for Applications – Friday 15th March (COB)

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 Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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 neurodiversity, 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.

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. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

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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GSK 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 GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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 GSK. GSK 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.

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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 (“the New HQ”) by end H1 2024. #J-18808-Ljbffr

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