Pharmacovigilance Physician (PVP) (f/m/d)

Job Description Summary

MiGenTra is seeking a Pharmacovigilance Physician (PVP) with a successful track record in drug development. The PVP will drive and oversee all Pharmacovigilance activities in MiGenTra’s biosimilar, cell and gene therapy, and vaccine development programs.

Key Responsibilities

• Oversee the benefit-risk profile of assigned development products
• Contribute to design, conduct and interpretation of clinical trials (pre- and post-marketing)
• Write and review clinical sections of trial documents including Investigator Brochure (IB), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, and submission related documents, etc.
• Ensure safety of trial participants and quality of trial data through ongoing medical monitoring and medical data review
• Be medical contact person for investigators, monitors, and CRO for all medical and safety related topics, including resolution of data discrepancies
• Plan, manage and oversee all Pharmacovigilance (PV) activities for assigned trials, including:
• Set-up of safety analyses and safety databases
• Medical assessments of SAEs, AESIs, DLTs
• Narrative Writing
• On time safety issue management in accordance with EU and country specific regulations
• Continuous monitoring of the product safety profile (across trials)
• Provide input on safety related aspects to regulatory dossiers/documents for marketing authorization applications and maintenances
• Provide regular safety updates to the CMO and the study team and recommend PV and risk management activities
• Responsible for subject inclusion issues and subject management issues that require medical judgment
• Establish, develop, and maintain contacts with investigators, key opinion leaders and clinical experts
• Provide training and medical input to all members of the clinical and study team
• Create and implement internal standard processes and documents, compliant to applicable domestic and international regulatory laws/standards

Qualification & Experiences

• Medical qualification (MD) required
• At least 10 years of clinical development (Phase 1-4) experience in pharmaceutical industry, including deep knowledge of applicable pharmacovigilance regulations
• Clinical Development experience, preferably in biosimilars and cell and gene therapies
• Proven ability to be flexible and adaptable within a changing dynamic environment and enjoy working in a fast-paced startup environment
• Goal orientation and ability to comprehend, structure and manage multiple parallel tasks
• Excellent knowledge of applicable regulatory framework and laws
• Excellent self-organization skills and team driven spirit
• Excellent communication skills in German and English (both written and spoken)
• Proficiency in MS-Office applications