Description:
Our client is a Commercial Global Biotech with drugs on the market in several locations worldwide! Due to continued success and growth, they are looking for a Medical Safety expert (MD) with Japanese language skills to support their Japanese affiliate as part of their global operations.
RESPONSIBILITIES
- Provide strategic medical safety leadership and practical contributions for Rare Disease portfolio
- Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
- Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
- Contribute to the development of the overall safety governance structure and activities
- Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
- Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
- Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
- Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
- Oversee the medical assessment of individual case safety reports (ICSR)
- Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)
- Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
- Provide medical safety contributions at internal audits and regulatory inspections
QUALIFICATIONS
- MD degree or equivalent required
- At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
- Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
- Demonstrated ability to perform medical assessments of safety data from multiple sources
- Experience with authoring complex documents and contributing to regulatory submissions
- Knowledge of adverse event reporting systems
- Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.