Shanghai (Associate) Director, Safety Officer China, MSPv SH 200050

Job description

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 implementation of any pharmacovigilance-related corrective and preventive actions (CAPAs); Deliver pharmacovigilance training to affiliate personnel and, as applicable, to vendors, if applicable; Represent MSPv at local audits and inspections in collaboration with MSPv and QA; Support the Head of Regions & Safety Operations or Director Safety Operations Officer APAC in the preparation and maintenance of pharmacovigilance agreements/safety data exchange agreements with local partners, and vendors What you have to offer: Master's Degree or similar degree in one of the following areas: preferred Medical (MD or equivalent), otherwise Life Science or Pharmacy 7+ years of all-round experience in pharmacovigilance and product safety within the pharmaceutical industry, biotech or CRO; 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; Team worker; inclusive attitude; Excellent communication skills towards the MSPv team; and to other BioNTech internal stakeholders comfortable to represent MSPv towards external stakeholders Experienced in usual business software (Word, Excel, Power Point) and pharmaco-vigilance database systems Your benefits and remuneration: