Medical Scientist as Safety Physician (m / f / d)

BioNTech SE; München; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Une entreprise biopharmaceutique de renommée mondiale recherche un Médecin de Sécurité Médicale pour rejoindre l'équipe de gestion d'études en oncologie. Vous travaillerez sur des protocoles, la formation des enquêteurs et l'évaluation des données de sécurité. Ce poste joue un rôle crucial dans la conformité réglementaire et l'amélioration continue des pratiques de sécurité.

Leistungen

Heures flexibles et politique de vacances

Culture inclusive

Soutien pour la santé et le mode de vie

Pension financée par l'employeur

Soutien à la garde d'enfants

Qualifikationen

• Diplôme en médecine requis, MD/PhD privilégié.
• Expérience en sécurité des médicaments dans l'industrie biopharmaceutique.
• Expérience avec les agences réglementaires sur les stratégies de développement.

Aufgaben

• Assurer la performance de l'équipe de gestion de sécurité.
• Gérer les demandes de sécurité pour les produits assignés.
• Développer les stratégies de sécurité pour les programmes d'oncologie.

Kenntnisse

Drug safety

Pharmacovigilance

Safety reporting

Signal detection

Regulatory engagement

Ausbildung

Medical Degree (MD or equivalent)

MD/PhD or relevant medical training

Jobbeschreibung

Mainz, Germany; London, United Kingdom; Munich, Germany | Full-time | Job ID: 8982

The Medical Safety Physician is assigned to one or more study management teams in the oncology therapeutic area and collaborates with Safety Scientists to provide Medical Safety Support. Responsibilities include contributing to clinical trial protocols, investigator training, safety data assessments, serious adverse event evaluations, safety signal detection, and ensuring compliance with GCP and reporting regulations. The Physician also contributes to safety reports, updates of reference safety information, the Investigator's Brochure, and Clinical Trial Reports.

Main Responsibilities:

• Ensure quality performance of safety management teams (SMTs)
• Oversee safety monitoring, signal management, and benefit-risk assessments throughout the product lifecycle
• Manage safety inquiries and concerns for assigned products
• Develop and implement safety strategies for oncology programs
• Engage with Regulatory Authorities on safety issues
• Oversee safety contributions to regulatory documents
• Represent MSPv in alliance management projects and collaborative development initiatives
• Serve as safety subject matter expert and arbiter for safety issues within the portfolio
• Ensure compliance with applicable laws and regulations
• Train and mentor Safety Physicians and Scientists

Qualifications:

• Medical Degree (MD or equivalent); MD/PhD or relevant medical training is a plus
• Extensive drug safety/pharmacovigilance experience in the biopharmaceutical industry, especially in immuno-oncology/inflammation
• Experience working with Regulatory Agencies on development strategies, particularly in the US
• Proven results in a matrix organization and multidisciplinary teams; experience in GCP standards and safety reporting

Benefits:

• Flexible hours and vacation policy
• Inclusive culture and opportunities to influence and shape safety practices
• Support for health and lifestyle, including company bike
• Employer-funded pension and childcare support