About this role
Associate Director, Safety Officer MSPv
Shanghai, China | full time | Job ID: 11394
Your main responsibilities are:
- Be the contact person for Safety Operations & Regions for the Territory China and liaising between MSPv and various local stakeholders on all Pharmacovigilance matters;
- Contribute to signal detection at clinical trial level: in close collaboration with the local medical monitors (including those of the partners); to ensure BNT are up to date on any new emerging safety information;
- Responsible for the receipt, processing, tracking and follow-up of serious adverse events from local sites participating in clinical trials sponsored by BioNTech or its Partners in China;
- Review/translate/forward SAE alerts/draft reports/source docs (in English);
- Support Data transfer activities in compliance with regulatory requirements;
- Conduct quality checks on single cases in EDC, clinical/safety database reconciliation, and query management;
- Contribute to generation of aggregate safety reports and ensure submission of (an adapted report) to the Chinese Authority; connect with the Authority on safety inquiries;
- Participate in Safety Management Team meetings, IRC meetings, etc.
- Assist with the preparation and submission of IND and clinical trial applications, the safety-related aspects of MAA and NDAs to the regulatory authority in China;
- Oversee and Support the implementation of risk minimization requirements concerning locally marketed products, including but not limited to (additional) risk minimization measures and product recalls in close collaboration with global functions and, where applicable, with BioNTech’s partners and vendors; Notification of the local regulatory concerning medicinal product risks and defects, (urgent) safety concerns, potential counterfeit products, in compliance with applicable law;
- Responsible for implementation of appropriate measures to ensure compliance with the applicable laws and regulations concerning personal data privacy legislation;
- Perform regular reconciliation/compliance activities for ICSR exchange with BioNTech Partners and/or vendor;
- 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 impl