Senior Director, Safety Officer

Role Overview

• Work in close partnership with global and local MSPv team member and cross-functional teams across clinical development, regulatory affairs , Quality and future commercial related teams to ensure compliance to Chinese safety and pharmcovigilance requirements;
• Work collaboratively and strategically with colleagues locally and globally across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our products to protect patients;
• Serve as the primary point of contact for senior cross-functional leaders locally and globally on matters related to patient safety and all Pharmacovigilance matters for China;
• Deliver professional guidance in developing comprehensive safety deliverables for China and actively participate in local Health Authority review boards and meetings as necessary;
• Develop and implement local pharmacovigilance-related procedural documents in accordance with global/company policies and with local regulatory requirements;
• Oversee and maintain compliance with company quality procedures and standards, the implementation of any pharmacovigilance-related corrective and preventive actions (CAPAs);
• Represent MSPv at local audits and inspections in collaboration with MSPv and QA;
• Drive the talent agenda: Leading people processes through recruitment, training, coaching and performance to meet all business requirements sustaining both global and local competitiveness and diversity

Requirements

• Master's Degree or similar degree in one of the following areas: preferred Medical (MD or equivalent), otherwise Life Science or Pharmacy
• 15+ years of all-round experience in pharmacovigilance and product safety within the pharmaceutical industry, biotech or CRO; PV head experience both in clinical development and post market is preferred
• Strong understanding of the drug development and drug licensing process.
• Expert knowledge of pharmacovigilance regulatory requirements in China and good understanding of global regulatory requirements;
• Experience in clinical trial safety management (e.g. including but not limited to case processing and signal detection process) according to ICH standards and local requirements.
• Experience in managing the local pharmacovigilance system, including but not limited to case handling and pharmacovigilance documentation;
• Fulfillment of local safety officer responsibilities;
• Experience in preparing for and responding to regulatory audits and inspections;
• Experience in Vendor and Partner Management.
• Competency in interaction/cooperation with other departments, partners, third parties and vendors;
• Fluent in written and spoken English language;
• Experienced with formal regulatory and legal language documents;
• Strong leadership and cross-cultural experience
• Strong problem-solving and decision-making skills in relation to working in a fast-paced start-up environment
• High degree of autonomy
• Ability to manage ambiguity and operate effectively
• Self-starter, ability to flex and change direction as business needs necessitate.

Benefits

• BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.