Patient Safety & Pharmacovigilance Coordinator
The position
Acts as Local Patient Safety Lead developing and defining the Ecuador and Peru Local Patient Safety & Pharmacovigilance (LPSPV) strategy based on the framework provided by global PSPV.
Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to safeguard patients’ and clinical trial subjects safety and public health in Ecuador and Peru in compliance with regulatory requirements and applicable internal procedures and processes.
Ensures compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.
Acts as Local Responsible Person for Pharmacovigilance (RPPV) for the National Health Authority for Ecuador and Peru as legally required.
Tasks and responsibilities
- Leads and develops the local PSPV team by living our behaviours, the Boehringer Ingelheim culture and One Medicine strategy.
- Initiates, evaluates, implements, and supports activities that are patient oriented and improve the status quo.
- Establishes and maintains a local PV system compliant with applicable regulations and Boehringer Ingelheim processes. Ensures that the local PV system is adequately described in the Local PV System Framework and applicable local documents (e.g., PV Repository, How to Guides).
- Prepares local periodic reports and local RMPs with country-specific format and content if needed in liaison with global Patient Safety & Pharmacovigilance (PSPV) functions for Peru.
Requirements
Required
- 5 years of Pharmacovigilance experience.
- Pharmacist. Major focus in Medicine, Pharmacy & Biochemistry and/or proven experience in Patient Safety & Pharmacovigilance.
- Comprehensive functional and technical skills in PV; demonstrates the capability of transferring the knowledge into practice, and ability to transfer previous experience in the Boehringer Ingelheim environment.
- Excellent leadership skills to manage a diverse team including in stressful situations.
- Working knowledge of Boehringer Ingelheim therapeutic areas, and the drug development process.
- Good technical knowledge of Pharmacovigilance databases.
- Sound expertise in GxP regulations.
- Intermediate English.