(Associate) Manager, Drug Safety Compliance

中国, 上海, Shanghai

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Principle Roles & Responsibilities / Accountabilities
Provide support in cross-functional interaction and communication for all safety relevant, and supervise all SRPL relevant activity is compliant to Roche safety SOPs and local regulatory requirements.
Support Drug Safety Compliance Manager in all DS activities at fully proficient level, including but not limited to: o Independently lead relevant project to build up clear cross-functional process to ensure PV oversight for relevant activity.
o Develop, supervise, simplify, enhance and implement local processes including but not limited to oversight of NIP/MAP, oversight of vendor with PV obligations, safety review and approval for projects/documents which might contain safety implications, and implementation of global and local requirements.
o Ensure non-safety Roche staff and relevant external partners to be trained with PV training with 100% compliance
o Audits and regulatory inspections readiness o Oversee and improve internal quality
o Develop and maintain local SOPs, working instructions and guidance in line with the company SOPs and local regulations
o Provide safety support and represent Roche China PV team to engage stakeholders to ensure better communication
Support Drug Safety Compliance Manager to develop an effective working environment and net, including but not limited to:
o Maintain connection with internal and external parties on safety matters, and serve as a Subject Matter Expert to bring safety expertise and advice to other departments when needed
o Ensure advanced product knowledge and drug safety expertise
o Mentor and coach junior team members

Education/Qualifications
Biological science, or pharmacy/pharmacology, or clinical medicine

Leadership Competencies
Demonstrated ability in cross-functional leadership.

Job Required Competencies
Relevant working experience: >1 years of experience in DS/clinical experience is preferable
Education: Biological science or Medical related background
Requirements on specific subject(s): No
Language: Fluent written and spoken English and Chinese with communication skills
Computer skill: Computer literacy
Other skills and/or competence:
o Drug safety expertise
o Medical knowledge of Roche products
o Presentation skill