Job Posting for Head of International Pharmacovigilance at _external, UCB
Help us transform patients' lives.
At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Patient Safety Team, based in one of our four main sites; US (Raleigh, NC), UK, Belgium or Germany we are looking for a talented individual to fill the position of: Head of International Pharmacovigilance.
As the Head of International Pharmacovigilance, you will oversee Patient Safety teams in USA, Europe Japan, China and International Markets. It requires cultural awareness, flexible working, strategic planning, technical expertise and substantial leadership skills.
Do you like to work in an environment where you can:
Be part of the evolution of UCB’s pipeline and portfolio, with increasingly frequent launches of products and new indications which will increase the complexity of the role.
Have an increasing strategic impact in continuing the evolution of the UCB ambition and activities in Japan and China.
Be a key member of the Leadership Team in a highly visible and impactful role which reports directly to the Head of Patient Safety and Medical Management.
You will contribute by:
Being responsible for managing Patient Safety teams in the UCB affiliates through the regional safety leaders (including talent identification and development).
Defining and ensuring execution of the Pharmacovigilance strategies at the affiliates including outsourcing where applicable.
Assuring a robust and healthy local Pharmacovigilance system with regulatory compliance and proactive audit and inspection readiness and on time/comprehensive management of observations.
Overseeing the China and Japan Safety team: Ensuring safety is providing strategic input into key deliverables and ensuring local requirements are met. Ensuring delivery of local pharmacovigilance and safety reporting, delivery of post approval safety studies, re-examination dossiers etc.
Building a culture of internal and external engagement to ensure that affiliate Patient Safety teams influence local ecosystem and network, are well informed and remain connected with the wider affiliate.
Proactively preparing and supporting launch activities for pharmacovigilance and risk management plan activities in collaboration with medical affairs.
Interested? For this position you’ll need the following education, experience and skills:
MD or higher medical qualification, PharmD or PhD or equivalent.
Significant experience in the biopharmaceutical industry with a proven and successful track record in at least three of the following areas: biopharmaceutical clinical development, risk management, pharmacoepidemiology, medical affairs or Pharmacovigilance.
Several years of pharmacovigilance experience in affiliates preferred.
Broad knowledge of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics.
Proven management and leadership skills that support and guide direct reports in the successful medical, scientific and project management of safety activities. Substantial and personal experience with GVP.
Substantial personal experience of inspections as well as presenting to and interacting with regulatory agencies essential to ensure adequate coaching of function members
UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.
With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.
Curious to know more? Please visit our website www.ucb.com.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.