Pharmacovigilance Services
Pharmacovigilance (PV) activities focus on monitoring, evaluating, and maintaining the safety profile of pharmaceutical products throughout their post-marketing lifecycle.
Regulatory authorities require companies to maintain appropriate safety documentation and periodic safety reporting to ensure continued benefit-risk evaluation of marketed products. Proper pharmacovigilance documentation supports regulatory compliance and helps companies maintain product approvals in different markets.
Our support is focused on pharmacovigilance documentation and reporting activities aligned with regulatory requirements.
When Do You Need PV Support
and What Are the Key Challenges?
Support for companies managing risk documentation, periodic safety reporting, and pharmacovigilance procedures across the product lifecycle.
This support is generally required in the following situations:
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Preparation of Risk Management Plans (RMPs)
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Periodic safety reporting for marketed products
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Preparation of PSUR / PBRER documents
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Development of pharmacovigilance SOPs
Companies commonly face challenges such as:
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Managing periodic safety reporting timelines
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Maintaining consistency across safety-related documents
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Aligning safety documentation with regulatory expectations
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Updating pharmacovigilance procedures and records
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Coordination of safety information during lifecycle activities
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Resource limitations for periodic PV documentation preparation
Our Approach and What You Will Get
Practical support for pharmacovigilance documentation, safety reporting, and process consistency across the product lifecycle.
Our approach focuses on practical support for pharmacovigilance documentation and reporting activities.
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Review of available safety and product information
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Preparation of Risk Management Plans (RMPs)
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Support for PSUR / PBRER preparation and compilation
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Preparation and review of pharmacovigilance SOPs and process documentation
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Support for post-marketing safety documentation activities
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Assistance in maintaining consistency across safety-related regulatory documents
Depending on project scope, deliverables may include:
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Risk Management Plan (RMP) documentation
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PSUR / PBRER preparation support
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Pharmacovigilance SOPs and process documents
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PV documentation review and gap assessment
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Periodic safety documentation support
Why Choose Tacit Medtek and Case Example
Practical, review-ready pharmacovigilance documentation support integrated with overall product lifecycle regulatory activities.
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Practical understanding of pharmacovigilance documentation requirements
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Support focused on regulatory safety documentation activities
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Structured and review-ready documentation approach
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Flexible support based on product and market requirements
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Integration of PV documentation with overall regulatory lifecycle activities
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Experience supporting pharmaceutical product lifecycle documentation
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Challenge: A pharmaceutical company marketing products in export markets required support for preparation of periodic safety documentation and standardisation of pharmacovigilance procedures across multiple products.
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Our Approach: Reviewed available product safety and regulatory information. Supported preparation of PSUR documentation for marketed products. Assisted in development and harmonisation of pharmacovigilance SOPs. Reviewed safety documentation for consistency with regulatory expectations. Supported updates to safety-related records during lifecycle activities.
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Outcome: The company improved consistency in pharmacovigilance documentation and strengthened readiness for periodic regulatory safety reporting requirements.
FAQ
Frequently Asked Questions
A Risk Management Plan (RMP) is a regulatory document describing identified and potential safety risks associated with a product along with proposed risk minimisation activities.
PSUR (Periodic Safety Update Report) and PBRER (Periodic Benefit-Risk Evaluation Report) are periodic safety reports prepared for marketed products to evaluate ongoing product safety and benefit-risk balance.
No. Our support is focused on pharmacovigilance documentation and regulatory reporting support activities.
Yes. We support preparation and review of pharmacovigilance SOPs and process documentation.
Yes. Existing PV documentation can be reviewed for consistency and regulatory alignment.
Yes. We support preparation and compilation of PSUR / PBRER documentation.
Yes. Support is available for updating safety-related documentation during product lifecycle activities.
Support can be provided for pharmaceutical products requiring post-marketing safety documentation activities.
Yes. We support review and gap assessment of available PV documentation and procedures.
Support can be provided for preparation of pharmacovigilance documentation aligned with applicable market requirements.
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