Associate Pharmacovigilance & Drug Safety Manager

Associate Pharmacovigilance & Drug Safety Manager

Bial

Porto, Portugal

MISSION:

BIAL is looking for an Associate Pharmacovigilance and Drug Safety Manager, to collaborate on the implementation and management of BIAL Group’s pharmacovigilance and drug safety system during clinical development, post authorization and commercialization phases.

MAIN ATTRIBUTIONS AND RESPONSIBILITIES:

  • Support the team in the establishment of a Pharmacovigilance network of BIAL Group in all countries where the company operates and in the exchange of drug safety information with affiliated companies, service providers and distribution and licensing partners;
  • Manage individual case safety reports processing within Global safety database;
  • Contribute towards managing the safety information management systems and tracking of the defined plans;
  • Contribute towards managing the system that ensures that all suspected adverse reactions reported to BIAL Group are registered and assessed so that they are available in the European Union system;
  • Understand the safety profiles and concerns regarding pharmaceutical products of the Bial Group;
  • Comply with Good Pharmacovigilance Practices (GVP) and Good Clinical (GCPs);
  • Comply with the Quality Environmental and R&D, Health and Safety Policies and Standards and Procedures.

REQUIREMENTS:

  • Degree in Health Sciences;
  • Pharmacovigilance experience of at least 2 years (preference);
  • Knowledge of Good Pharmacovigilance Practices and Good Clinical Practices (preference);
  • Management of individual case safety reports processing within Global safety database;
  • Attention to detail and organization skills;
  • Assertiveness and good communication and interpersonal skills;
  • Fluency in English (written and spoken);
  • Good IT skills.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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