Senior Manager Pharmacovigilance – Budapest, Hungary
Date posted: June 30, 2020
Location: Budapest, Hungary
The Senior Manager, Pharmacovigilance will manage and direct the company’s pharmacovigilance projects. Develops and maintains the necessary processes to ensure high quality. Supports and leads the pharmacovigilance activities of the company. Works with internal and external stakeholders to ensure that safety data is processed according to applicable regulations. Serves as pharmacovigilance and safety expert in cross-functional teams.
Roles and Responsibilities:
- Develop processes and SOPs to ensure all safety information is collected and process in accordance with FDA, EMA and ICH requirements
- Oversight of day to day safety monitoring activities and safety operations for all investigational and marketed products
- Manage Adverse Events reporting and develop case report
- Author and/or review for periodic safety regulatory documents according to the agreed process and timelines.
- Manage and maintain safety database
- Interface with internal and external stakeholders with respect to pharmacovigilance and safety reports.
- Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
- Manage routine signal detection processes; identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
- Contribute to and/or review the pharmacovigilance component of contracts/agreements and escalate any deficiencies to management to ensure quality and integrity of agreement
- QPPV qualifications is a plus, but not mandatory
- Relevant degree, preferably in life science.
- At least 5 years of direct pharmacovigilance work experience in pharma or CRO
- Working knowledge of relevant FDA, EMA and ICH guidelines, initiatives, and regulations and a comprehensive understanding of Global Pharmacovigilance regulatory obligations
- Hands on experience with safety databases
- Working knowledge of MedDRA, WhoDrug Global, INH-CTCAE
- Demonstrated ability to build a Pharmacovigilance Team using external vendors, internal resources and consultants