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Associate Director, Configuration Management

2 months ago

London, Greater London, United Kingdom VONQ Full time
Job Title: Associate Director, Configuration Management

We are seeking a highly skilled Associate Director, Configuration Management to join our team at VONQ. This role will provide a unique opportunity to lead key activities and progress your career in a dynamic and challenging environment.

Key Responsibilities:
  • Provide a channel between the configuration of the PV system and 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.
  • 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.
Requirements:
  • Degree in information sciences, life sciences, or a medically related field.
  • 5-10 years of 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 prioritization and time management.
  • Effective communication skills.
Preferred Qualifications:
  • 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 VONQ?

VONQ 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 VONQ a place where people can thrive. We want VONQ 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.

VONQ 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.

Important notice to Employment businesses/Agencies

VONQ 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 VONQ's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to VONQ. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and VONQ. 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 VONQ. VONQ 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, VONQ may be required to capture and report expenses VONQ 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 VONQ's compliance to all federal and state US Transparency requirements. For more information, please visit VONQ's Transparency Reporting For the Record site.