Join Our Mission to Improve Lives Worldwide
Collaborates on the implementation and management of BIAL pharmacovigilance and drug safety system during clinical development, post authorization and commercialization phases, through medical revision of the safety information received, in compliance with the applicable legislation.
The Impact You'll Make
* Perform medical review of safety reports, regulatory documents and publications related to the safety of BIAL medicinal product;
* Conduct medical monitoring of BIAL medicinal products, to search and evaluate potential safety signals (signal management) and to answer safety related questions;
* Provide timely answers to medical queries related to the safety of the BIAL medicinal products, requested by internal or external stakeholders (e.g, Competent Authorities or other relevant entities);
* Comply with the Good Pharmacovigilance, Clinical and/or Laboratory Practices, as applicable;
* Comply with the Quality, Environmental, R&D, Health and Safety Policies, Standards and Procedures;
* Collaborate in other activities of the team, when necessary.
What You'll Bring
* Degree in Medicine;
* Knowledge of Good Pharmacovigilance Practices, Good Clinical Practices, Epidemiology and Biostatistics;
* Good ability and ease of communication and interpersonal relationship;
* Autonomy and good planning capacity, organization;
* Good IT skills.
This is a temporary position to cover a maternity leave.