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Associate Director, PV Systems Application Development
Site Name: UK - London - New Oxford Street, Durham Blackwell Street, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence
Posted Date: May 14 2025
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 requires the candidate to be on-site a minimum of 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 practices; 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
Key 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 promptly.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Bachelors 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: 04 June 2025
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 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 by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform peoples lives.
GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science, technology, and talent to get ahead of disease together.
Find out more about our approach to R&D and why GSK is a great place to work.
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