Deputy Local Safety Officer

Make your mark for patients

We are looking for a Deputy Local Safety Officer to join us in our Global Pharmacovigilance Team based out of our office in Oakville, Ontario, Canada.

About the role
The Deputy Local Safety Officer (LSO) will facilitate bringing UCB closer to becoming a preferred and trusted safety partner for patients, health care professionals and regulators by driving best in class/industry practice in pharmacovigilance for the UCB affiliate. The Deputy LSO will assist to identify and proactively control risks related to local pharmacovigilance, including compliance risk, operational and vendor risk.

Who you’ll work with
The Deputy Local Safety Officer will interact with multiple levels and diverse functions (commercial, quality, regulatory, legal, medical) within and outside UCB (regulators, patients, HCP’s, Pharma industry associations).

What you’ll do

1. Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements.
2. Identify and clearly articulate evolving local needs (regulation changes, eco-system changes, etc.) impacting Pharmacovigilance and as required work collaboratively with corporate Pharmacovigilance and other cross functional stakeholders (e.g. IT, Medical) to develop and implement solutions.
3. Work in close collaboration with corporate Pharmacovigilance teams to contribute in the maintenance of the UCB PV system according to regulatory requirements and UCB standards.
4. Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to relevant corporate pharmacovigilance functions (including Global/EEA QPPV), local stakeholders.
5. Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Pharmacovigilance and Quality Assurance.
6. Ensure that all information relevant to the benefit/risk balance of the UCB products is reported to corporate Pharmacovigilance (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation.
7. Act as local Subject Matter Expert on product safety, contributing to the product lifecycle activities, product information (e.g., labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Management Plan as applicable.
8. Engage and build trust through transversal collaborations with affiliate and corporate stakeholders to secure pharmacovigilance compliance.

Interested? For this role we’re looking for the following education, experience and skills

1. Bachelor's degree in a relevant field
2. 2+ years in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements
3. Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to meet compliance requirements
4. Excellent oral and written communication skills with the ability to interact with multiple levels and diverse functions (e.g. commercial, quality, regulatory, legal, medical) within and outside UCB (e.g. regulators, patients, HCP’s, Pharma industry associations)
5. Demonstrated ability to understand, analyze, and summarize scientific and medical information
6. Ability to lead and motivate and influence in a matrix organization

UCB Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.