BioNTech SE
(Senior-) Director Head of Medical Review (Pharmacovigilance)(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
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BIBioNTech SE
Director Safety Physician(m/w/x)
Mainz, München
ab USD 168.100 - 268.700 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Medical safety expertise for oncology drug development, including clinical trial protocol contributions and investigator training. MD/PhD and extensive drug safety experience required. Annual bonus and equity.
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Anforderungen
- Medical Degree or equivalent
- MD/PhD and/or certified training in medical discipline (plus)
- Extensive drug safety/pharmacovigilance experience
- Experience in innovative drug development
- Experience with BLA/MAA submissions
- Advisory committee experience
- Experience in immuno-oncology/inflammation therapeutic areas (preferred)
- Exposure to regulatory agencies on development strategies
- Direct experience with regulatory agencies on development strategies
- Experience with innovative oncology product development strategies
- Experience with US regulatory agencies (particularly)
- Demonstrable results in matrix organization
- Demonstrable results in multidisciplinary team
- Experience implementing GCP standards in clinical trials
- Experience with safety reporting compliance
Aufgaben
- Support oncology therapeutic area with medical safety expertise
- Collaborate with Safety Scientists to ensure patient safety
- Contribute to clinical trial protocols
- Train investigators on safety procedures
- Assess safety data, including adverse events and serious adverse events
- Determine necessary follow-up actions for safety concerns
- Conduct safety signal detection and evaluation
- Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting
- Contribute to Development Safety Update Reports (DSURs)
- Update reference safety information
- Revise Investigator Brochures
- Prepare Clinical Trial Reports
- Oversee safety monitoring and signal management
- Manage benefit-risk of assigned products throughout the product life cycle
- Identify and lead escalation of safety inquiries and concerns
- Formulate and drive optimal safety strategy for oncology programs
- Present and interact with Regulatory Authorities on safety matters
- Oversee quality content of safety contributions to clinical and regulatory documents
- Participate in due diligence for BioNTech’s Licensing/Acquisition initiatives
- Represent MSPv in Alliance management projects
- Negotiate safety data exchange agreements
- Serve on joint oversight committees with development partners
- Ensure activities comply with applicable laws and regulations
- Train and mentor Safety Physicians and Safety Scientists
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mitarbeiterrabatte
- Variety of benefits
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