The selected candidate will ensure the implementation of BIAL drug safety management and pharmacovigilance (PV).
Establish a PV network for Bial in all countries where it operates and ensure the exchange of drug safety information with affiliated companies, CROs, and distribution and licensing partners;
Supervise security information management systems;
Coordinate, document and communicate product safety assessments;
Ensure that training is provided on legislation and GPV norms of the Bial Group;
Establish and manage a system to ensure that all suspected adverse reactions (ADRs) reported to Bial are collected and evaluated and collected so that they are available at least one point in the European Union;
Ensure a prompt and comprehensive response to any requests for information from authorities regarding information they consider necessary;
Supervise the quality management system for GVP including quality assurance and control procedures, compliance monitoring, SOPs, training and audits.
Degree in Medicine or Pharmaceutical Sciences;
10 years’ experience in PV;
Knowledge of GVP, GCP, Epidemiology and Biostatistics;
Ability to plan and manage priorities;
Assertiveness, good communication and interpersonal skills;