Description:
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
- Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements.
- 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.
- 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.
- 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.
- Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Pharmacovigilance and Quality Assurance.
- 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.
- 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.
- 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
- Bachelor's degree in a relevant field
- 2+ years in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements
- Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to meet compliance requirements
- 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)
- Demonstrated ability to understand, analyze, and summarize scientific and medical information
- Ability to lead and motivate and influence in a matrix organization