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Reporting to the Senior Director, Pharmacovigilance & Drug Safety, the Pharmacovigilance & Drug Safety Specialist collaborates in implementing and within the management of Bial Pharmacovigilance and Drug Safety system during clinical development, post authorization and commercialization phases, in compliance with the applicable legislation.
The Impact You'll Make
* Collaborate in the establishment of a Pharmacovigilance network of Bial in all countries where the company operates and in the exchange of drug safety information with affiliated companies, service providers, distributors and partners;
* Contribute towards the safety information management systems and to the monitoring of defined plans;
* Collaborate on the evaluation of product safety (e.g., PSURs - Periodic Safety Update Reports);
* Support the assessment of quality defects and quality issues with the potential safety impact;
* Collaborate in the training on the Pharmacovigilance procedures of the Bial;
* Contribute towards the management of the system that ensures that all suspected adverse reactions reported to BIAL are collected and assessed so that they are available in at least one point in the European Union;
* Understand the safety profiles and concerns regarding BIAL medicinal products;
* Collaborate to ensure a prompt and comprehensive response to any request for information performed by the authorities regarding necessary information for the benefit-risk assessment of BIAL medicinal products;
* Contribute towards quality management system regarding Good Pharmacovigilance Practices that includes quality assurance and quality control procedures, compliance monitoring, SOPs, training and audits.
What You'll Bring
* Degree in Pharmaceutical Sciences or similar areas;
* Solid knowledge of Good Pharmacovigilance Practices;
* Previous experience in GVP audits and inspections;
* Advanced IT skills;
* Very good planning and organization skills;
* Assertiveness and good communication and interpersonal skills;
* Knowledge of epidemiology and biostatistics (preferred).
This is a temporary position to cover a maternity leave.
Create Your
"I work together with people from various backgrounds, with different expertise and beautifully complex personalities – and I love that"
Carmen Denecke Muhr (Global Medical Affairs Manager – Parkinson's, Germany)