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 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
- 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