Comprehensive Pharmacovigilance SOPs
What Is a Pharmacovigilance SOP?
Pharmacovigilance SOPs, or standard operating procedures, are written instructions that outline the processes and steps involved in monitoring the effects of drugs, helping ensure the adverse event reporting procedures or drug safety monitoring are consistent. These detailed instructions should comply with regulatory requirements and industry standards.
An SOP covers detailed procedures for conducting risk assessments and storing or retrieving pharmacovigilance data. It includes detailed steps for conducting literature searches, monitoring the safety literature, and assessing their impact. The procedures for communicating with healthcare providers and regulatory agencies must also be included in the SOP.
What Makes a Thorough SOP?
The main purpose of writing an SOP is to ensure the pharmacovigilance activities are carried out efficiently and in the same manner. So how do you write a thorough SOP? We have tips below:
- Keep it simple and concise. Anyone reading the SOP shouldn’t have trouble understanding and following each step of the process. Include definitions for jargon —or better yet, avoid jargon as much as possible. An SOP shouldn’t contain any fluff; include relevant information only.
- Use active voice only. Avoid writing in passive voice to improve clarity.
- Include all steps. Never skip a single step. All relevant details must be in the SOP.
Our Skilled Writers Can Help You Write Your SOPs
Do you need an SOP service provider? Our comprehensive pharmacovigilance SOPs are fully auditable and reviewed regularly. Please contact us today to learn how we can help create or improve your pharmacovigilance SOPs.
