The Position Collaborate in the development and implementation of the Local PS & PV strategy based on the framework provided by the integral PSPV.
Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to safeguard the safety and public health of patients and clinical trial subjects in accordance with regulatory requirements and applicable internal procedures and processes.
Ensures compliance with external requirements in accordance with local photovoltaic legislation and applicable internal procedures and processes that enable the company to obtain and maintain marketing authorization for its products. TTasks and responsibilities Collaborate in the Local PSPV strategy with patient safety as ultimate goal, including defining the local product activities/initiatives.
- Advocates the Patient Safety & Pharmacovigilance strategy to interfaces within BI.
- Develops and implements other functions activities to enhance PSPV culture and PSPV awareness in line with global recommendations.
- Understands the pharma market dynamics, trends .
- Actively networks with external stakeholders to exchange on new and emerging topics related to PV and contributes, where applicable/possible, to impact the pharmacovigilance landscape. Initiates, evaluates,



implements and supports activities that are patient oriented and improve the status quo.
- Fosters innovation by brainstorming with internal and external partners/stakeholders on new approaches and challenging the status quo for new products, services or collaborations.
- Responsible for management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation and archiving) including PV reporting to local Health Authorities/Ethics Committees in line with applicable external regulations . -Ensures appropriate PV training in the respective territory;
- Manages local Pharmacovigilance Agreements (PVAs) in cooperation with General Partner Management and provides adequate localized PV clauses/language to the Legal/Purchasing Department as well as guidance for implementation and support for individual contracts;
- Ensures that an up-to-date Business Contingency Plan is in place; Requirements Required 1 -2 years of Pharmacovigilance experience . Comprehensive functional and technical skills in PV; demonstrates the capability of transferring the knowledge into practice, and ability to transfer previous experience. Good technical knowledge of Pharmacovigilance databases

📌 Patient Advocacy Specialist (Lima)
🏢 Multinational Pharmaceutical
📍 Lima