Biosimilars are an important development for patients globally. The opportunity to provide patients with greater access to critical therapies furthers our mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product.
The Global Safety Medical Director serves as the safety expert for the Biosimilar development products, establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned Biosimilar products in development.
Applicable tasks may vary by product(s) assigned. The activities can be delegated to CRO or Safety Scientist while remaining accountable of the activities.
- Clinical Trial Safety
- Product safety profile, benefit-risk evaluation, and risk communication
- Signal detection, evaluation, and management
- Periodic (aggregate) safety reporting
- Investigator’s Brochure and Informed Consent Form
- Risk management and minimization – RMP
- Marketing applications/BLAs and other regulatory filings
- Regulatory authority queries
- Inspection Readiness
- MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications (as above, and additionally):
- 4+ years of directly related industry pharmacovigilance experience
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Experience in Investigational Drug development and lifecycle management
- Filing/BLA experience is a plus
- Experience working effectively in teams with diverse cross functional members and interests
Preferred Pharmacovigilance skills:
- Clinical trial safety knowledge and experience
- Safety activities of signaling and routine data review, aggregate reports (such as the DSUR), Investigator’s Brochure, Informed Consent Forms etc.
- Clinical Study Reports and related activities (relevant to safety)
- Risk Management Plan document generation and review
- Application of medical concepts and terminology
- Ability to analyze and interpret complex safety data
- Ability to convey complex, scientific data in an understandable way
- Basic skills in application of statistical and epidemiological methods to pharmacovigilance
- Document writing skills in presenting safety data and evaluation
- Regulatory agency responses and interactions