Standard Operating Procedures (SOPs) form the foundation of every compliant pharmacovigilance (PV) system. They ensure that all PV activities are carried out in a consistent, traceable, and reliable manner - from adverse drug reaction (ADR) handling to literature screening and signal management.

According to EU GVP Module I and Module II, pharmaceutical companies must establish and maintain documented processes for all relevant PV tasks. These processes must be supported by comprehensive SOPs that clearly define:

Responsibilities and task ownership
Interfaces between departments and partners
Workflows and quality safeguards

Missing or outdated SOPs can lead to deviations, inefficiencies, and inspection findings - ultimately jeopardizing your compliance status.

SOPs are also closely tied to your Pharmacovigilance System Master File (PSMF). Inconsistencies between SOPs and the PSMF can be identified as non-compliance during inspections. A harmonized and well-documented system strengthens both quality and regulatory standing.

Creation & Maintenance of PV SOPs

Why SOPs Matter: Regulatory Requirement and Operational Backbone

Practical, Compliant, and Tailored

Development of New SOPs

I create SOPs based on current regulatory frameworks (EU GVP, national legislation) - tailored to your company's structure and needs.

Workflow Design in Alignment with Daily Practice

Together with your team, I design and implement practical PV workflows to ensure seamless integration into daily operations.

Complete PV System Setup

I support you in building a fully documented PV system - including all required SOPs and aligned PSMF content.

Review & Revision of Existing SOPs

I analyze and revise your current SOPs to reflect regulatory updates and improve clarity, efficiency, and usability.

My Services

SOPs That Fit Your PV System and Daily Practice

Harmonization Across the SOP Landscape

I harmonize and standardize SOPs for better integration into your existing Quality Management System (QMS).

Gap Analysis & Compliance Checks

I identify documentation gaps or inconsistencies that could compromise compliance or inspection readiness.

Training and Implementation Support

I introduce new or revised SOPs to your team through onboarding, targeted training, and clear guidance.

Ongoing SOP Maintenance

I regularly review and update your SOPs to reflect regulatory changes and evolving best practices.

✔ Regulatory Compliance

Your SOPs are aligned with EU GVP and national requirements - minimizing the risk of findings during audits and inspections.

✔ Efficient, Scalable Processes

Clearly defined procedures reduce errors, delays, and misunderstandings - without creating unnecessary workload.

✔ External Expertise, Internal Empowerment

You benefit from expert implementation while building sustainable in-house knowledge through training and knowledge transfer.

✔ Seamless Integration into QMS

SOPs are harmonized across departments and fully embedded in your Quality Management System.

✔ System-wide Readiness

You receive a fully structured PV documentation landscape - ready for inspection and aligned with global requirements.

✔ Practical, Usable SOPs

I prioritize clarity and applicability - so your SOPs are not only compliant but also functional in daily operations.

Your Benefits

Clarity, Compliance, and Confidence

pharmacovigilance expert writing standard operating prodedures with laptop

Looking to strengthen your PV system with clear, compliant SOPs?

Let’s talk about how I can support you - whether you're building a new system, updating existing procedures, or preparing for inspection.
Contact me for tailored SOP support.

Get in Touch