Safety Data Manager

Há 7 dias

Lisboa, Lisboa, Portugal GrabJobs Tempo inteiro
Responsibilities and Requirements

The successful candidate will be responsible for monitoring and ensuring the safety and efficacy of our client's pharmaceutical products. The following responsibilities and requirements apply:

  • Responsibilities:
  • Review and evaluate adverse event reports and other safety-related information for our client's products.
  • Perform case processing activities, including data entry, coding, narrative writing, and quality checks.
  • Conduct signal detection activities and contribute to the preparation of signal evaluation reports.
  • Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
  • Participate in the development and implementation of pharmacovigilance processes and procedures.
  • Assist in the training and mentoring of junior team members.
  • Maintain knowledge of current regulatory requirements and guidelines related to pharmacovigilance.
  • Ensure compliance with company policies and standard operating procedures.
  • Contribute to the continuous improvement of pharmacovigilance activities and systems.
  • Fuency in multiple European languages, both written and spoken.
  • Minimum of 2 years of experience in pharmacovigilance or a related field.
  • Strong knowledge of pharmacovigilance practices and regulations.
  • Experience with case processing activities, including data entry, coding, and narrative writing.
  • Proficiency in using pharmacovigilance databases and safety reporting systems.
  • Ability to work independently and prioritize tasks effectively.
  • Excellent attention to detail and accuracy in data entry and documentation.
  • Strong analytical and problem-solving skills.
  • Good interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams.
  • Experience with MedDRA coding and EudraVigilance is desirable.
  • Flexibility to work in different time zones, if required.
Requirements

The following requirements must be met by the successful candidate:

  • Education and Experience:
  • Minimum of 2 years of experience in pharmacovigilance or a related field.
  • Degree in life sciences or a related field.
What We Offer

Luminary Group offers a competitive salary and benefits package to the successful candidate.

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