Pubblicato su stage4eu il: 14/05/2019
MSD, Intern Safety Data Specialist - Pharmacovigilance Management Job
Chłodna 51, Warsaw, Polonia
Under the direction of a manager and direct supervision of a SDS/Senior SDS/Lead SDS, the Intern Safety Data Specialist (SDS-Intern) is responsible for analyzing, triaging and processing of all adverse experience information received for investigational products, according to standard operating procedures (SOPs) for further reporting to worldwide regulatory agencies by Global Pharmacovigilance. In addition, the SDS-Intern collaborates with other staff within the organization, as well as cross-functionally.
- Performing data entry of adverse experience information from investigational environment or processing another, homogenous type of safety reports (e.g. regulatory forms).
- Through daily case prioritization activities, completing reports within the established timeframes to ensure compliance with internal, business partner (BP), and regulatory agency reporting requirements worldwide.
- Participating in training and certification activities for Global Pharmacovigilance Case Management (GPVCM).
- A bachelor's degree and above, preferably in medicine, pharmacy, nursing or biological sciences.
- Excellent organizational, workload prioritization and time management skills.
Excellent overall communication skills with advanced oral and written English skills.
Advanced computer skills.
Independent, strong analytical and problem solving skills.
Good sense and awareness of regulations and policies.
Ability to work under time pressure in a changing environment with flexibility.
Strong sense of responsibility and accountability.