Vigilare International
 | |
| | |
| Type | Public / Private |
| Founded | 2014 |
| Headquarters | 375 EAST ELM STREET, SUITE 230, CONSHOHOCKEN, PA 1942 |
| Key people | James A. Bannon, Pharm D., President and CEO
Angela K. Pitwood, MBA, Vice President |
Contents
Overview
Vigilare International provides top pharmacovigilance and contact center services, ensuring the most effective safety and risk management solutions for any client's trial’s needs. The company is a full safety services organization providing pharmaceutical, biotechnology, and medical device companies with a full range of product safety services. The company are proud to have seasoned industry leaders with a unique combination of safety, pharmacovigilance and therapeutic expertise, with the added benefit of strong international business experience.
Quality is an integral driver for all of Vigilare offerings. Pharmacovigilance personnel are highly educated healthcare professionals who undergo stringent training. An overarching Quality Management Plan assures the highest level of consistency, continuity and quality of data.
Vigilare International has 45 years of combined leadership experience; this assures clients that projects are managed effectively and efficiently.
Services
Consulting and Quality Assurance Services:
- Inspection Readiness
- QA Audits
- CAPA Creation, Tracking and Management
- GAP Analysis and Suggested Remediation
- Transformational Change Management
- Systems Validation
- Due Diligence
Medical Information and Product Contact Center:
Inbound and Outbound- Web and Telephony Services
- Medical Information Inquiry
- Tracking
- Documentation
- Fulfillment
- Adverse Event Contact Intake and Follow-up
- Product Quality Complaint
- Report Tracking
- Transfer
- Patient Outreach
- Patient Contact Programs
Adverse Event Processing:
Complete a Partial ICSR Management
- Case Receipt and Data Entry
- MedDRA, WHO-Drug Dictionary Coding
- Narrative Writing
- Quality Control
- Assessment and Medical Review
- Submission of Reports to Health Authorities and Stakeholder
- Health Authority Liaison
Risk Management and Aggregate Reporting:
- Periodic Safety update Reports (PSURs/PBRERs)
- Periodic Adverse Experience Reports (PADERs)
- Development Safety Update Reports (DSUR)
- Review of Line Listing
- Signal Detection Activities
- Regulatory Interactions and Product Support
- Risk Management Plans/REMS
Operational Approaches
Turnkey Pharmacovigilance Processes & Systems
- Fully validated database
- Full set of SOP’s
- All Staffing is provided and managed via Key Performance Indicators
- Detail QA Plan
- CAPA
Staffing Model
Vigilare provides experience pharmacovigilance staff to work within clients system
- ARGUS and/or ARISg experience
- Managed and directed by client’s PV management
- Staff trained on client SOP’s and systems
Hybrid Approach
- Combine Turnkey and Staffing model
- Custom solution based upon client needs
Top 5 Recent Tweets
| Date | Author | Comment |
|---|---|---|
| October 31, 2018 | jobsxlusa | Pharmacovigilance Manager https://t.co/mUqmrqLqjI |
