According to the Public Relations Department of Actoverco Group, Dr. Baharak Mahdipoor, speaking at the 2nd National Conference on Health Product Vigilance held at the School of Pharmacy, Shahid Beheshti University of Medical Sciences, highlighted the company’s 13 years of experience in developing its pharmacovigilance system. She emphasized the importance of timely reporting, effective documentation, and the active participation of all organizational departments in ensuring patient safety.
Referring to the establishment of Actoverco’s independent pharmacovigilance unit in 2013, she explained that the initiative was initially launched in response to international requirements related to pharmaceutical import activities. The system was subsequently developed under the supervision of Merck and through collaboration with other international business partners, including Ferrer and Rubio.
Dr. Mahdipoor stressed that identifying and assessing potential adverse drug reactions and risks play a vital role in maintaining a favorable benefit-risk balance. She also highlighted the importance of fostering a blame-free reporting environment, describing organizational learning from incidents and preventing their recurrence as fundamental principles for improving performance.
In another part of her presentation, Dr. Mahdipoor discussed the importance of the Pharmacovigilance System Master File (PSMF). Noting that the development of this document had been part of Actoverco’s pharmacovigilance system from its early stages, she emphasized that the PSMF should not merely serve as a collection of documents prepared to meet regulatory requirements or presented during inspections. Rather, it should provide an accurate reflection of the organization’s structure, responsibilities, and operational processes.
She further explained that consistency between documented procedures and actual organizational practices, along with regular updates reflecting structural and procedural changes, are essential to an effective pharmacovigilance system. Proper documentation not only promotes transparency but also enables organizations to identify weaknesses and pursue continuous performance improvement.
Concluding her remarks, Dr. Mahdipoor described patient safety as a shared responsibility across all organizational departments and emphasized the importance of ensuring that every employee understands their role in reporting and promptly communicating drug safety information.
Continuous Monitoring and Improvement of Pharmacovigilance Systems
Dr. Roshna Matin, Pharmacovigilance Manager at Actoverco, also delivered a presentation focusing on the documentation requirements and structure of the Pharmacovigilance System Master File (PSMF).
Emphasizing the importance of continuous monitoring and the documentation of supporting evidence, she described pharmacovigilance system improvement as an ongoing process requiring regular assessments, identification of areas for improvement, and follow-up on corrective actions.
Dr. Matin noted that reviewing and documenting system performance involves much more than preparing a single file. The objective, she explained, is to provide a clear picture of the system’s current status, its progress, and the evidence demonstrating the outcomes of implemented activities.
She also recommended periodic reviews of different components of the pharmacovigilance system, encouraging colleagues to examine existing documentation, identify deficiencies, and assess whether sufficient evidence is available to demonstrate the effectiveness of implemented measures.
According to Actoverco’s Pharmacovigilance Manager, even identifying gaps and documentation deficiencies during the initial assessment can serve as a valuable starting point for planning and implementing corrective actions and continuously enhancing system performance.
The 2nd National Conference on Health Product Vigilance was held on October 21, 2026, at the School of Pharmacy, Shahid Beheshti University of Medical Sciences, with the aim of facilitating the exchange of successful pharmacovigilance experiences among pharmaceutical companies.
