Pharmacovigilance Consultant
Aveo Oncology - Cambridge, MA

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AVEO is seeking a contract Pharmacovigilance professional to support the Pharmacovigilance team. The incumbent will report to Manager of Pharmacovigilance and will have a supporting role in shaping and maintaining the Pharmacovigilance function/ department.

Responsibilities:

Responsibilities include the following:
  • May act as the PV representative on Clinical Trial teams and participate in review of product and study documents
  • Supports other departments with regard to PV activities and services
  • Participates in SAE reconciliation activities, SAE tracking and resolution of site specific issues with regard to PV activities
  • Participates in processes relating to regulatory reporting requirements
  • Participates in the development, maintenance and expansion of the team’s medical/scientific and regulatory knowledge required to support drug safety activities
  • Assists with monitoring compliance and additional quality metrics
  • May perform selected quality control activities with regard to SAE narratives, queries, tracking, and regulatory submissions
  • Ensures compliance with corporate and departmental SOPs
  • May participate in the improvement of internal safety infrastructure and processes
  • Performs other assigned activities under the oversight of management, such as preparation for internal safety review meetings and updating process documents

Qualifications:
  • BS/ MS/ RN/ degree and background in biomedical science, pharmacy or health sciences with 4+ years in pharmaceutical pharmacovigilance, or relevant industry experience.
  • Knowledge of FDA and international adverse event reporting regulations per International Conference of Harmonization (ICH) Guidelines and the ability to interpret and apply applicable regulations to resolve issues.
  • Solid understanding of the relationship between PV and cross functional drug development processes
  • Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases
  • Consistent attention to detail, strong organizing skills, and understanding of workflow prioritization
  • Experience with drug safety databases and MedDRA coding is essential. ARISg experience is a plus.
  • Ability to make initial clinical judgment and seek medical oversight

Aveo Oncology - 13 months ago - save job - block
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