Posted on Apr 20, 2021 by Michael Bailey Associates - Zurich
Not Specified, Switzerland
1 May 2021
- Collect and communicate metrics data as related to the ongoing assessment of pharmacovigilance quality, consistency, compliance and operational effectiveness.
- Collaborate with other SMEs to develop, improve and align pharmacovigilance procedures and documentations including SOPs, conventions, forms, templates or other internal documents.
- Work closely with other departments on developing and aligning strategies and processes related to pharmacovigilance quality and compliance.
- Monitor the implementation of post-marketing pharmacovigilance commitments and responses to audit observations.
- Plan for and actively participate in regulatory inspections, internal audits or cross-functional strategic quality initiatives.
- Coordinate Pharmacovigilance Corrective Action/Preventive Action (CAPA) plans including training, response strategy, root-cause analysis, and documentation.
- Serve as the Subject Matter Expert (SME) on pharmacovigilance training; review training needs and requirements for AMAG employees, contracted resources, vendors or business partners as applicable. Prepare, and as needed deliver drug safety training and monitor compliance with training requirements.
- Assist with pharmacovigilance project planning and management.
- Provide quality review for aggregate periodic safety reports prior to submission to ensure that safety data provided for these documents are consistent and accurate.
- Ensure that the current safety reference documents are available and consistently utilized for ICSR processing, aggregate report generation and safety data analyses.
- Monitor current regulatory requirements and trends regarding pharmacovigilance.
- Manage open cases and upcoming submissions to ensure compliance with submission timelines.
- Assist with case processing.
- Bachelor's degree in pharmacy, nursing, life sciences or equivalent. Masters, Pharm. D. or other advanced degree in life sciences is a plus.
- Prior industry experience including pharmacovigilance/drug safety operations, process development, project management or training.
- Working knowledge of guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting.
- Knowledge of drug safety databases (Argus or Arisg).
- Hands on experience in end-to-end case processing.
- Strong organizational skills and demonstrated ability to focus on quality with attention to details.
- Demonstrated ability to set priorities, work independently and collaboratively.
- Fluency in written and spoken English.Experience in quality control and/or quality assurance in the pharma industry.
- Experience with regulatory inspections and pharmacovigilance system audits.
- Knowledge of MedDRA and WhoDrug coding principles and practical applications.
- Excellent written and oral communication skills.
- Proficiency in the use of Windows and MS Office applications and ability to learn new systems as needed
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.