Bristol Myers Squibb Associate Director International Operations & PV Intelligence in Braine L'Alleud, Belgium

Associate Director International Operations & PV Intelligence

Purpose/Objective of the job

  • Ensure operational excellence in support of the International Organisation

  • Align company policy and practices with legislative requirements to ensure compliance.

  • Oversee projects relating to International Pharmacovigilance

Key Responsibilities and Major Duties

  • Management EU PV office

  • Collaborate and support Quality Standards and Training (QST) in relation to quality standards & metrics for the International PV Organisation

  • Support the International PV organisation in the gathering, interpretation and implementation of regulations and guidances.

  • Support audit and inspection readiness and International Pharmacovigilance training

  • Oversee projects relating to International Pharmacovigilance

Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)

  • International Managers

  • EU PV Coordinator

  • International Project Support, as applicable

All above functions are specific to activities related to EMA submissions and support the QPPV in particular and the International Organisation as appropriate

Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients:

  • GPV&E - HQ and WW LMs

  • GRS and R&D Quality

  • Clinical

  • Medical/Commercial

  • Business Partners

  • EPIA/EMA

Requirements:

  • University degree (preferably health or life science) or nursing qualification.

  • At least 5- 10 years in the Pharmaceutical Industry, usually with at least 5 years’ experience working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment. Experience in people management

  • Demonstrated strong, effective organizational, facilitation, interpersonal and communicating skills with cross functional teams locally/regionally and within GPVE to achieved desired outcomes.

  • Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs).

  • Subject matter expert in local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS). Clearly articulates implications of changes. Contributes actively to the implementation of new legislation and GPV&E procedures/systems. Monitors and ensures adherence to local/regional/global regulatory requirements and relevant GPV&E procedures.

  • Utilizes effective decision making and a problem-solving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability.

  • Ability to manage multiple tasks and utilize effective problem-solving approaches and independently follows up and resolves outstanding issues.

  • Successful and creative negotiation of difficult safety/compliance issues

BMS BioPharma Behaviors required

  • Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.

  • Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.

  • Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.

  • Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled