- Recruitment Type：Social Recruitment
- Work Type：Full-Time
Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project level.
Interact with license partners to support the Alliance Management in the preparation and maintenance of PV agreements.
Provide medical review of individual safety cases (providing medical expertise and judgement).
Provide medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
Proactively identify safety signals, conduct benefit-risk assessments using safety data and literature available.
Prepare/review Risk Management Plan (RMP), provide expertise on the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the RMP. Provide medical input to ensure that risk-minimization strategies are implemented appropriately in relevant documents.
Provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
Ensure appropriate clinical safety risk communication and escalation to company Drug Safety Committee.
Ensure effective and timely delivery of aggregate reports including PSUR/PBRERs and DSUR.
Provide medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Contribute to safety relevant parts in IND/NDA submission package; support cross-functional teams with regards to PV aspects when preparing IND/NDA submission package.
Two years or more of clinical experience as well as at least 3 years of pharmacovigilance experience, or overall equivalent experience profile.
Good knowledge of international guidelines GCP/GVP.
Specialty certification is preferred.
Good knowledge of pharmacovigilance relevant regulations (especially in China and Asia) and industry standards.
Proven evidence of effective delivery of high-quality safety relevant documents.
Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics.
Effectively communicates in written and spoken English.
Communicates complex issues in an understandable, effective and relevant manner.
Strong influencing skills with the ability to explain and defend a position in the face of opposition.
Strategic focus on activities and planning, with proactive planning and prioritization skills.
Effective team member. Takes ownership of appropriate issues and appropriately delegates.
Effectively applies processes across assigned team.
Excellent analytical and problem-solving skills.
Provide effective and relevant review of complex documents.
Experience with the PV “Tool box” regarding databases/ other IT/ Coding systems.
- Work Experience：Working experience not required
- Language：Not Required