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Regional Pharmacovigilance, Intercontinental Lead

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Mascot, NSW

  1. Research & Development
  2. Pharmacovigilance
  1. Full-time
R00111015

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn


Job Description

The Opportunity 

This position is responsible for day-to-day direct oversight of operations and compliance activities to maintain high-functioning PV systems in all affiliates across assigned region remit. The Regional Lead is a key partner for Affiliate Safety Representatives and Affiliate/Regional Medical Directors in driving PV excellence across the affiliates. Reports directly to Area PV Head. This position is responsible for day-to-day direct oversight of operations and compliance activities to maintain high-functioning PV systems in all affiliates across assigned region remit. The Regional Lead is a key partner for Affiliate Safety Representatives and Affiliate/Regional Medical Directors in driving PV excellence across the affiliates.

Reports directly to Area PV Head.

What you'll be doing: 

  • Accountable for the day-to-day oversight of resources executing compliance and operational activities in affiliates within assigned region. Accountable for oversight of Affiliate and Regional compliance and operational performance PV metrics, inclusive of work performed by internal employees, contractors and outsourced partners. Ensures PV systems across affiliates, in region, maintain a high-performing state.
  • Proactively anticipates affiliate-specific or cross-affiliate operational issues and opportunities, within Region, through a deep understanding of the evolving regulatory environment, trends of operational metrics and understanding of evolving affiliate and regional business priorities. Analyzes metrics and compliance indicators (lagging and leading) to promptly address underperformance or drive continuous improvement initiatives that will enable high performance of the Affiliate PV systems within region. Ensures timely communication of operational issues and compliance risks to Area PV Head and key stakeholders.
  • Accountable for audit and inspection readiness across region. Prepares and presents data during regulatory audits and inspections. Responsible for development of responses to operations-related findings and drives timely implementation of corrective/preventive actions.
  • Ensures team members are well trained on PV processes and systems and have the required competencies to fulfil their responsibilities in the changing business and regulatory environment. Maintains local PV procedures and ensures alignment with local legislation. Demonstrates a strong understanding of global PV processes and systems. Provides PV strategic and operational expertise to team members. Ensures consistent implementation of PV operational processes across region. May be required to be an SME, within the Regional Model, for assigned PV processes and be the go-to leader for routine process-related guidance.
  • Ensures that PV operations are in compliance with local PV regulations. Reviews local PV legislation and partners with Affiliate Safety Representatives to define impact to operational activities. Drives action plans to implement required changes to PV operations. Facilitates coordination with Area PV Head and PSEQ governance committees for escalated decision making on process variances. Manages communication and connections with Medical Directors on process governance decisions.
  • Conducts regular operational review meetings with Affiliate Safety Representatives (ASRs) to communicate metrics and insights on health of the Affiliate PV operations. Conducts site engagements to conduct training for Affiliate PV teams and strengthen relationships with ASRs and Medical Directors. Collaborates with ASRs on opportunities to enhance the partnership. Partners with Medical Directors to ensure coverage of ASR role and backup role. Ensures business continuity plans are in place for Affiliate PV systems. Responsible for oversight and implementation of the back-up strategy for affiliates where the ASR is the sole PV resource in-country.
  • of PV operations and compliance across the Region is well-understood and communicated across key stakeholders.
  • Partners with other Regional PV Leads, Regional Area PV Product Leads, Risk Management Implementation Leads and other key PSEQ stakeholders to share insights and learnings crucial to maintaining a high-performing PV system in the Affiliates within region. Provides regional operational PV insights to inform Area PV strategy.
  • Accountable for successful implementation of Global PV operational initiatives within region.
  • Participates in the recruitment, selection, hiring and transitions of ASRs. Accountable for onboarding of Affiliate Safety Representatives (ASRs). Implements the defined PV learning strategy within region. Provides strategic input to inform talent management cycle strategies and decisions for ASRs (and their teams). Ensures strong connectivity and two-way information flow between Regional PV team members and Affiliate PV teams. Supports ASRs in connecting with PV leaders and experts across PSEQ. Proactively identifies resource needs and escalates to Area PV Head.
  • Fosters a culture of trust, connection, cross-functional advocacy, curiosity and unification within team. Partners with PSEQ International Strategy and Sites Lead in the implementation of cultural and community activities internationally.
  • Actively builds and strengths collaborative partnership with Medical Directors. Serves as a key member of the Affiliate and Regional Medical Directors Leadership Team to provide strategic PV input to Affiliate and Regional priorities and strategic plans. Anticipates operational PV needs based on Affiliate/Regional initiatives and plans, e.g. product launches, pipeline plans and business development strategies. Ensures that the health

Qualifications

​​​​​​Experience you will need to be considered:

  • A minimum of 5-7 years experience required within the pharmacovigilance field including extensive experience in overseeing PV operational and compliance metrics
  • Advanced scientific degree (e.g. PhD, PharmD, MD). Prior experience leading small to medium sized teams   
  • A minimum of 3-4 years with direct people management experience for medium to large teams
  • Demonstrated understanding of the complexities and success measures of working in the global highly matrix environment.
  • Experience in implementing and delivering transformation programs. Proven leadership skills to lead and influence cross-functional matrix teams.
  • Strong effective communicator and ability to influence across the enterprise ability to partner and build strong relationships and role model leadership behaviors.

 


Additional Information

Let's create a more inclusive world together

AbbVie is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We strongly believe that diverse perspectives are essential for achieving exceptional outcomes, and we actively encourage applications from individuals of all ages, nationalities, abilities, and cultures. We are committed to providing equal opportunities for all employees and ensuring a fair and inclusive recruitment process. If you have any specific requests or accessibility requirements, please inform us at the time of application (via nikki.hughes@abbvie.com), and we will make the necessary adjustments to accommodate your needs.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.