Make your mark for patients
We are seeking an innovative, strong communicator and influencing Head, Global Safety Data Integration and Literature to join our leadership team in the Product Pharmacovigilance & Device Safety team, ideally based in our Raleigh, NC or Brussels, BC offices.
About the role:
You will play a pivotal role in oversight and implementation of new and improved solutions to develop best in class safety business processes for standardized data collection in line with patient safety strategic objectives. You will act at the primary point of contact within UCB for any regulatory queries and interactions with health authorities and lead Mission Regulatory discussions internally as part of the Patient Value Unit.
Who you'll work with
Reporting to the Head of Global Safety Reporting Operations, this position consolidates global and affiliate safety data integration owning the intake and literature screening process for UCB's full product portfolio, including drugs, biologics, and combination products across all geographies. This is a pivotal position in an evolving regulatory and technology focused environment that requires the ability to work with international and cross-functional teams, and the ability to interact with regulators during inspections and audits.
What you'll do:
Lead the execution of a comprehensive strategy for efficiently collecting safety information from multiple potential sources, including spontaneous reports, clinical studies, market research, social media, literature, and license partners.
Stay updated on the latest trends and emerging developments in safety data collection. Utilize this knowledge to drive continual improvements in processes leveraging technology, aligned with Patient Safety's automation objectives.
Ensure that collection methodologies facilitate timely, complete, and high-quality data, streamlining efficient case processing operations.
As the business process owner, drive the implementation of technology solutions to enhance data collection efficiency, supporting streamlined ICSR intake and literature operations while maintaining data accuracy and compliance.
Coordinate and lead a project team with affiliate teams to advocate for harmonization of intake processes, improving standardized procedures with vendors wherever possible, fostering consistency.
Serve as deputy delegate to Global Safety Reporting Operations Head and account for oversight of literature screening and management activities.
Provide oversight of advanced analytics and reporting capabilities to develop volume forecasting projections, identify trends, and potential risks.
Interested? For this position you'll need the following education, experience, and skills:
Bachelors' degree in health sciences, business or related field is required and master's degree preferred.
At least 5 years in the pharmaceutical industry in leadership roles relevant to pharmacovigilance.
Well defined experience with safety databases and case processing activities.
Demonstrated experience leading teams within the pharmaceutical industry, preferably in product pharmacovigilance & device safety teams.
Versed in serving as a lead in ICSR and Literature vendor management for governance oversight, optimizing vendor relationships, workload analysis and strategic capacity modelling.
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on ******** for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 87254
Recruiter: Chris Venegas
Hiring Manager: Elizabeth Humes
Talent Partner: Katie Elizabeth Coyle
Job Level: MM I
Please consult HRAnswers for more information on job levels.
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