Pharmacovigilance & Drug Safety Manager

Pharmacovigilance & Drug Safety Manager

Bial

Porto, Portugal

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Reporting to the Director, Pharmacovigilance & Drug Safety, the Pharmacovigilance & Drug Safety Manager maintains BIAL Pharmacovigilance and drug safety system during clinical development, post authorization and commercialization phases, in compliance with the applicable legislation and support procedures in quality assurance and quality control, compliance monitoring, SOPs, Pharmacovigilance training and audits.

The Impact You’ll Make

  • Collaborate within the establishment of a Pharmacovigilance network for BIAL in all countries, where it operates and in the exchange of safety information with affiliated companies, service providers, distributors and licensing partners;
  • Contribute towards the safety information management systems and to track defined plans;
  • Collaborate within the evaluation of product safety (eg. Periodic Safety Update Reports, Risk Management Plans) and to support the assessment of quality defects and quality issues with potential safety impacts;
  • Collaborate on the Pharmacovigilance training of BIAL Pharmacovigilance SOPs and on the Pharmacovigilance training activities;
  • Contribute to the management of the system that ensures that all suspected adverse reactions reported to BIAL are collected, and evaluated so that they are available in at least one location in the European Union;
  • Have knowledge of the safety profiles and all concerns regarding BIAL medicinal products;
  • Collaborate to ensure prompt and comprehensive response to any request made by authorities regarding information they deem necessary for the benefit-risk assessment of BIAL medicinal products;
  • Provide inputs on the preparation of regulatory actions in response to emerging safety concerns (e.g. variations, urgent safety restrictions and communication to the patients and healthcare professionals);
  • Assume preparation and maintenance of the BIAL Pharmacovigilance Quality Assurance and Quality Control Procedures, compliance monitoring, SOPs, training and audits;
  • Provide support on the management of the Pharmacovigilance budget;
  • 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 Pharmaceutical Sciences or similar areas;
  • Solid knowledge of Good Pharmacovigilance Practices;
  • Previous experience preparing Aggregate Reports;
  • 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 Good Clinical Practices (preferred);
  • Knowledge of epidemiology and biostatistics (preferred).

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