Our PM team and Business Units are PrimeVigilance’s champions of collaborative partnership, accountability and quality.
At PrimeVigilance, effective management of pharmacovigilance, vigilance and clinical safety pivot around the project manager: our PMs manage project(s) timelines, ensuring deliverables are met within budget and on time, plan for risk mitigation and overcome challenges that arise whilst they provide unwavering operational excellence. We believe that partnership is the foundation of any successful collaboration. Our team’s success relies on a proactive engagement with you.
Through our distinct PM business units we offer tailored product development expertise.
Business Units
Clinical Safety
Instrumental in setting-up centralized safety databases, collation and filing of documentation to eTMF and in the management of multiple protocols for the same IMP to allow for consistent processing and safety reporting obligations to be streamlined across sponsor's portfolio. It has also been involved in the development of study specific documents (SMP, SAE/pregnancy form) and core documents e.g., protocol, filing plan, reconciliation plan, to ensure process alignment and efficiencies.
Post-Marketing Innovative/Brand Products
Covers the safety management for innovative/brand medicines, whether ATMP, biologics, devices and combination products following their commercialization
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Post-marketing Generics, Hybrids and Biosimilars
Dedicated to supporting safety services for approved biosimilars, hybrids and generics
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Post-marketing Vaccines
Dedicated in managing all safety prerequisites for vaccines following regulatory approval.
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At PrimeVigilance we have taken pride in:
- Becoming an integral part of our customer’s safety teams
- Sharing our extensive Pharmacovigilance and Regulatory expertise with you and benefit your program/development project either via outsourcing, consulting (our solutions) or their combination to match your capabilities and business needs
- Investing into our partnership with clients. The partnership model is based on executive engagement and governance, resource planning and strategy, identification and rigorous assessment of efficiencies in resources, technology and PV operations
- Monitoring our clients’ satisfaction and continuously improve or adapt our all-embracing services to best match your corporate objectives.
