Associate Director, Configuration Management
The key purpose of this role is to provide a channel between the configuration of the PV system, and the system users, Global Safety teams, PV system vendors, GSK source system teams, IT suppliers and back again in three key areas- systems delivery, systems validation, and systems support
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Responsible for understanding and applying clinical safety and pharmacovigilance data, processes, and regulations
- Accountable for conducting thorough searches of source systems and confirming data
- Tasked with interacting with source system owners to strategically develop alignment
- Responsible for understanding and applying PV system configuration.
- Accountable for having thorough knowledge of PV reference systems
- Responsible for understanding and using medical and drug/vaccine/device terminology
- Tasked with interacting with external system vendors to participate in strategic development planning
- Responsible for ensuring adherence to GSK's and external regulators' computer system validation guidelines for the development and maintenance of PV Systems
- Tasked with interacting with Safety System stakeholders to confirm configuration requests and implemented changes
- Accountable for interacting with internal and external regulators in support of the PV system
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Degree in information sciences, life sciences or medically related field and
- 5- 10 years experience in safety system management Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology;
- general understanding of worldwide regulatory requirements
- Comprehensive understanding of safety data and ability to apply to PV systems and associated source systems.
- Understanding of general principles around product development, computer systems, and regulatory requirements.
- Solid computer skills and computer literacy (e-mail, word processing, PowerPoint, prefer experience with relational databases, i.e. ORACLE)
- In-depth understanding of medical and drug terminology Proven experience of prioritisation and time management Effective communication skills
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- SQL Knowledge, ability to understand simple to medium complexity queries
- SQL Developer usage, ability to copy and update simple queries
- Data Visualization- Presentation of data enabling decision makers to see analytics presented visually, to understand difficult concepts or identify new patterns Data cleansing, processing, and identifying questions
- Project management
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.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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