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Associate Director, PV Information Systems
2 months ago
We are seeking an experienced Associate Director to lead our Pharmacovigilance and Safety Systems team. The successful candidate will be responsible for managing and maintaining our global safety database and associated reporting and signaling tools.
Key Responsibilities- Lead and Contribute to Safety Technology Implementations
- Implement new safety technologies, including global safety databases and reporting tools.
- Oversee the evaluation and implementation of safety system upgrades and integrations.
- Translate User Requirements into Functional and System Requirements
- Utilize pharmacovigilance expertise to translate complex user requirements into functional and system requirements.
- Manage Global PV Processes
- Own, manage, and execute activities associated with global PV processes, including computerized systems administration, change control, and change management.
- Provide Data Support
- Provide data support for ad-hoc, signal detection, audit, and authority inspection outputs and listings.
- Lead Cross-Functional Teams
- Lead cross-functional teams with stakeholders, affiliates, and vendors to collect and implement PV specifications and user requirements.
- Drive Resolution of Complex Issues
- Work in a fast-paced collaborative team environment and drive resolution of complex, cross-functional issues.
- Support Business Process Owners
- Support business process owners to support SaBR business initiatives, including coordination, communication, and change management.
- Write and Review Validation Lifecycle Documents
- Write and review validation lifecycle documents.
- Assist with Systems Onboarding Curriculum and Training
- Assist with the development and maintenance of SaBR systems onboarding curriculum and training.
- Education and Experience
- Degree in a business, scientific, or technical discipline, or equivalent.
- Prefer minimum of 12 years of total biotech/pharmaceutical industry experience, including at least 8 years in a technical drug safety/pharmacovigilance role.
- Subject Matter Expertise
- Subject matter expert for PV systems, database administration, computerized system validation, and data retrieval.
- Technical Skills
- Good understanding of drug safety and pharmacovigilance and of all aspects of drug development.
- Some knowledge of Electronic Data Capture (EDC) systems and data structures.
- Understanding of GxP and ICH guidelines.
- Leadership and Communication Skills
- Strong leadership skills, including demonstrated ability to lead a cross-functional team and influence at all levels of an organization.
- Excellent oral and written communication skills, including presentation and facilitation.
This is a sedentary role that requires the ability to lift files and open filing cabinets. The job operates in a professional office environment and routinely uses standard office equipment.
Travel RequirementsSome travel will be required, up to 15%.
