Senior Pharmacovigilance Manager Associate (PV systems)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
The PV Manager leads safety database oversight ensuring data quality regulatory compliance and system optimization. This role supports reporting validation training and cross-functional collaboration while driving continuous improvement and team mentorship.
Role and Responsibilities
- Lead the development and delivery of complex standard and custom reports to meet evolving regulatory requirements and strategic internal needs.
- Oversee database design set-up and configuration ensuring alignment with protocol and product-specific requirements in collaboration with IT Safety and Project Management teams.
- Lead validation efforts for computerized PV systems maintaining compliance with GxP 21 CFR Part 11 and other regulatory frameworks.
- Strategically manage data migration activities between legacy and modern safety databases ensuring integrity traceability and completeness throughout.
- Develop and deliver advanced training programs on safety database processes ensuring smooth onboarding and upskilling across regions.
- Act as a Subject Matter Expert (SME) for safety system configurations supporting global pharmacovigilance processes.
- Oversee Cumulative Data Quality Reviews (CDQRs) and drive proactive data integrity initiatives across safety platforms.
- Drive the creation implementation and refinement of SOPs guidelines and work instructions pertaining to safety database operations.
- Champion continuous improvement initiatives to optimize database performance user experience and compliance posture.
- Collaborate with global cross-functional teams (IT QA Regulatory PV Operations and Commercial) on system enhancements issue resolution and client delivery excellence.
- Provide strategic input and support to the Business Development and Commercial teams for proposals RFPs and client engagements representing safety systems capabilities.
- Mentor and coach junior PV team members building internal capabilities around safety systems and process excellence.
- Represent the PV Systems function in audits and inspections and ensure readiness of database-related documentation and processes.
Qualifications :
- Life Science or Project Management Business Analysis or IT Development Related Degree
- Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company biotech or CRO (on premise or cloud-based solution)
- Organizational skills including attention to detail and multitasking
- Management skills including time and issue management
- Communication skills
- Presentation skills
- Ability to motivate/coach people
- Leadership skills
Additional Information :
Why PrimeVigilance
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly supportive working environment
Opportunity to work with colleagues based all over the world with English as the company language
Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Disaster Recovery
- Business Process
- SQL
- Active Directory
- VMware
- Customer Service
- Information Technology
- data integrity
- Windows
- Project Management
- Troubleshoot
- System Administration
- Management System
- Procedures
- hardware
About Company
Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more
