
Pharmacovigilance Manager
- Bogotá DC
- Permanente
- Tiempo completo
- Set up and manage the local pharmacovigilance system
- Local Literature Search
- Local ICSR Management
- PV Intelligence Screening
- Local PSMF Maintenance
- Setting up local Organized Data Collection
- Local PVA Management
- Local adaptation and submission of PSUR / RMP
- Local signal detection
- Implementation of additional Risk Minimization Measures
- Reviewing materials relating to local post-authorization safety
- Participate in PV-relevant audits and inspections
- University degree in Life Science
- Several years’ experience and profound knowledge in the field of pharmacovigilance
- Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance
- Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads).
- Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
- Good communication skills (written and verbally); capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills.
- English business fluent & local language (as appropriate).