Job Description
Location : ***working fully remote during COVID-19***
1 year contract (extension possibilities)
Job Summary
This senior manager position guides and leads safety signal management processes and activities reporting to the Signal Management and Safety Governance Lead. Ensures that safety signal management processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Supports Signal Management and Safety Governance Lead in developing and maintaining signal management processes to maximize patient safety.
Key Activities
- Contributes to the provision of quality metrics specified within the Signal Management Metrics Control Plan and recommends improvement opportunities identified from process improvement initiatives
* Contributes to process improvement initiatives aimed to improve pharmacovigilance and quality capabilities related to signal detection and management
* Provides support to the development and implementation of training and communication plans for changes in business processes
* Provides training to support implementation of process changes related to signal detection, signal management, and safety governance
* Represents the activities of signal management process in internal and external meetings
* Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
* Supports inspection and audit activities
* Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Knowledge and Skills
* Pharmaceutical industry or health authority experience.
* Pharmacovigilance processes and EU, FDA and international regulatory requirements
* Quantitative and qualitative signal detection methodologies and safety data analysis
* Safety Information tracking and pharmacovigilance systems
* Experience in supporting inspections or internal audits
* Understanding of commercial processes and vendor interactions
* Written and oral communications, leadership and problem solving
Education & Experience (Basic)
3 years of pharmacovigilance or signal management experience
OR Bachelor's degree and 5 years of pharmacovigilance or signal management experience
Top 3 Must Have Skill Sets:
- Hard Skills (3+ years of experience)
- PV experience
- drug development/clinical experience (science-based)
- ARGUS experience (1 year of experience)
- Project Management
- Safety Experience
