PVASC Associate Director

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Provide strategic oversight of indirect reports who provide support for activities related to SDEA/PVASCs by:

• Ensuring that the direct reports provide the respective team support in consistently, efficiently and reliably delivering to regulatory requirements, third party commitments (implementation, maintenance and termination of SDE/PVASC) and organizational expectations and driving quality across the team.
• Ensuring the teams are staffed by appropriately skilled and trained individuals so that the team can successfully meet the required performance standards
• Developing and sharing pharmacovigilance and technical knowledge and experience with team members, with proven ability to support and coach direct reports
• Identify cases of potential noncompliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues
• Participate in quality or continuous process improvement activities related to area of responsibility or as requested
• Maintain good documentation practice and be the Point of Contact in case of inspection/audit.
• Provide inputs and support to site head in meeting the high-level objectives and assist in designing vision for the team.

Responsibilities:

• Perform activities related to the implementation, maintenance and termination of SDEA/PVASCs
• Deliver safety data and PVA reports Configuring safety data and SDEA-related information within the GSK Safety and Pharmacovigilance Agreements (PVA) databases
• Accountable for managing and tracking SDEA/PVASC agreements and SDEA/PVASC obligations and reporting KPI status against SDEA/PVASCs periodically to Management
• Ensure SDEA/PVASC compliance through monitoring, reconciliation, quality control and support for oversight
• Deliver training and/or project support as required
• Implement, maintain and improve processes in alignment with GSK policy to ensure that SDEA/PVASCs are maintained throughout their lifecycle and to ensure that GSK and partners comply with the terms of executed agreements.
• Accountable for the maintenance of the SDEA/PVASC database and provision of data for the PV Master File
• Delivering training and/or project support as required

• Balance resource requirements across the portfolio and promote a pragmatic, flexible, focused approach to workload
• Define relevant objectives for the teams
• Ensure all the teams have effective Management Monitoring of the Activities
• Ensure issues affecting people and process across the teams are dealt with high importance
• Ensure that direct reports have business objectives set, development plans in place and complete all assigned training
• Develop and share technical, pharmacovigilance, SDEA/PVASC and PV systems knowledge and experience with team members
• Collect data on time, cost, quality and compliance and ensures team meets targets for all measures including defined Key Performance Indicators (KPIs)
• Aid in Inspections/Audit. Constructing root cause analysis for the findings, non-conformities and CAPA for the same
• Aid direct reports with decision-making, problem solving and work prioritization; provide review and quality check support as required
• Lead in quality or continuous process improvement activities related to area of responsibility or as requested
• Maintain appropriate organizational networks
• Recognize matters that affect corporate or agency policies and escalate issues with high business impact or risk

Complexity (this is best illustrated for this role by the behaviors needed to perform effectively):

• Leadership: Sets direction for the team to make them understand how their work supports the team's goals and the organizational priorities and applys sound judgment to all that they do.
• Decision Making: Makes well thought-out yet efficient decisions based on pertinent facts, relevant information and good judgment. Identifies key issues, analyses cause-effect relationships, clarifies input from different sources, and reaches appropriate decisions in a timely manner.
• Embracing Change/Innovation: Questions the status quo. Generates new ideas. Recognises the need for new or modified approaches and brings perspectives and approaches together, combining them in creative ways.
• Teamwork: Works effectively with others to achieve business goals and objectives. Bridges personal, business and cultural differences to work effectively in team settings.
• Business Orientation: Understanding of the operational challenges of safety stakeholders and other customers. Recognises issues and initiatives important to the business in order to facilitate development of business benefits cases and effective prioritization or process improvements in order to move the business forward. Coordinates with partners regarding new strategies to ensure consistent communication strategies. Implements processes that foster a cross-organisational approach to achieving the mission and strategic goals.Customer Focus: Understands their (internal and external) customer's business. Understands customers' needs and works with them to help solve their problems. Acts quickly to respond to customers' needs.
• Communication: Listens to others: actively attends to and conveys understanding of the comments and questions of others; listens well in a group. Speaks effectively: speaks clearly and expresses self well in groups and in one-to-one conversations. Writing skills: conveys information clearly and effectively through both formal and information documents; reviews and edits written work constructively. Delivers presentations effectively: prepares and delivers clear, smooth presentations; carries self well in front of a group. Strong influencing and negotiation skills.
• Coaching: Educated in Coaching Model and coaches individuals in many situations as opportunities arise. Seeks opportunities to take on the role of coach for others. Provides feedback routinely and demonstrates effective coaching skills in a way that preserves self-esteem and encourages success for an individual and within the organisation.

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

• Bachelor/Master degree (Information Management/ Technology, Computer/ life science, pharmacovigilance or other relevant scientific field)
• Minimum of 10+ years working experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

If you have the following characteristics, it would be a plus:

• Pharmaceutical industry or related experience with relevant systems experience strongly preferred
• Experience supporting GxP compliant systems
• Regulatory inspection / audit experience
• Knowledge of key pharmacovigilance regulations and methodologies
• Excellent people management skills
• Can communicate effectively in local language and English.
• Coach and mentor a large team
• Engage proactively with other PV managers / leaders to help develop and drive strategy
• Build relationships with stakeholders external to Global Safety Department
• Seek process improvements at a global level
• Adapt to changing technology
• Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers
• Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way with appropriate attention to detail.
• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
• The position holder provides leadership to her/his team to ensure the members are adaptable to changing workload and responsibilities while effectively delivering support to the expectations of Safety and GSK leadership
• Ability to define and implement new processes and quality initiatives.
• Strong interpersonal, presentation and communication skills

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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