Associate Director, PV Systems Application Development

Job title:

Associate Director, PV Systems Application Development

Company

GlaxoSmithKline

Job description

We are seeking a skilled individual to join our team as the Associate Director, PV Systems Application Development. This pivotal role acts as a key liaison between stakeholders and end-users of Pharmacovigilance (PV) computer systems, and IT service providers, ensuring seamless systems delivery, validation, and support.The successful candidate will demonstrate expertise in project management, business and data analysis, and systems validation, while effectively managing IT suppliers and providing comprehensive support to a global users within safety.The role required the candidate to be on-site a minimum 2 days per week.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 webpageKey Responsibilities

• Project Management: Lead multidisciplinary teams to achieve the delivery of computer systems and associated technology on time, within budget, and at the required level of quality in accordance with organizational goals and objectives.
• Business Analysis: Utilize innovative and logical thinking to map complex operational needs into robust, clear systems requirements. Perform impact analysis to ensure no negative effects on other systems and processes. Contribute to the strategic PV systems roadmap, participate in new software/systems evaluations, and proactively identify areas for new systems and technology by maintaining awareness of industry trends and regulatory changes worldwide in pharmacovigilance.
• Data Analysis: Extract, inspect, clean, transform, and model raw data to highlight useful information, suggest conclusions, and support decision-making.
• Systems Validation: Plan, execute, and report on user acceptance testing, and archive test findings for diverse regulated systems. Produce evidence of systems validation for internal and external auditors, demonstrating that procedures, processes, and activities consistently lead to expected results.
• Training: Educate and instruct end-users and other stakeholders using efficient and effective communication. Structure complex changes in a form relevant and applicable to the operational needs of users.
• Support: Respond to client or end-user requests by diagnosing and resolving problems and incidents within defined guidelines. Escalate or transfer problems to other technical support teams or outside vendors as appropriate. Provide timely and expert resolution and advice, including configuration maintenance, query and reporting support, and managing helpdesk requests. Work across the organization to resolve end-user requests and incidents in a timely manner.

Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree (BS/BA) in a scientific or medically related field, or equivalent experience in the pharmaceutical industry, specifically in clinical development, pharmacovigilance, and information management.
• Experience managing safety databases.
• Comprehensive understanding of pharmacovigilance (PV) and drug safety system lifecycle management.
• In-depth knowledge of clinical safety and pharmacovigilance data, processes, and regulations.
• Thorough knowledge of database management, and systems analysis and design.

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

• Proficiency with ARGUS safety database.
• Strong background in information management.
• Thorough knowledge of safety database structure, data elements, and data retrieval principles.
• Thorough understanding of iQMS/SDLC framework and procedures.
• Working knowledge of vendor management skills and best practices.
• Working knowledge of service management practices.

Closing Date for Applications – 31 Jan 2025 (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.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:.Why GSK?Uniting science, technology and talent to get ahead of disease together.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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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 or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.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 and scroll to the Careers Section where you will find answers to multiple questions we receiveAs 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.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

London

Job date

Sun, 19 Jan 2025 05:19:13 GMT

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