Pharmacovigilance Medical Writing
PV Solutions medical writing team is well-experienced in writing different types of PV documents and can provide a comprehensive solution to a client for aggregate reporting. Our medical writers also undergo continuous training and have the ability to prepare documents in accordance with relevant guidelines. We can support you with the writing of various documents such as:
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMSs);
- Pharmacovigilance System Master Files (PSMFs);
- Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs);
- Addendum to Clinical Overviews (ACOs);
- Periodic Adverse Drug Experience Reports (PADERs);
- Developmental Safety Update Reports (DSURs);
- Standard Operating Procedures (SOPs);
- Literature search, analyses and ad-hoc benefit-risk assessments.