Associate Director / Director Pharmacovigilance (PV)
Accountable for LaNova overarching pharmacovigilance (PV) activities for ongoing and upcoming clinical trials in international regions and China, for the assigned products.Ensure LaNova PV activities to comply with company standards and fulfill China and other countries health authority requirements, reach the target of mitigating risks and protect all subjects/patients exposed to LaNova products.
Accountable for pharmacovigilance activities for clinical research of assigned products.
Ensure reporting compliance with regulatory agency reporting requirements worldwide and define individual study safety management/surveillance scheme.
Responsible for (Risk Control Plan) RCP, Development Safety Update Report (DSUR), analysis of similar events (AOSE) or periodic safety summary report when needed and etc.
Perform medical review from safety perspective for individual SAE from clinical trials, including provide company comments for causality assessment against investigator’s assessment.
Perform safety signal detection base on obtained safety data from clinical trials.
Serve as an expert by ensuring the appropriate SOPs and guidelines are available and routinely updated. Stay abreast of regulatory updates.
Provide technical level process expertise and conduct periodic assessments to ensure established processes are being followed in a consistent and timely manner. Provides training as necessary.。
Hires, mentors and manages direct reports, as needed. Develops and maintains individual objectives and goals; reviews performances and evaluates activities of direct reports, for harmonized performance.
MS or MD in medicine or relevant areas, clinical background is preferred.
Industry experience of which 7-10 years is relevant to pharmacovigilance/drug safety knowledge
Good verbal, written and presentation skills in English and Chinese
Knowledge of medical and drug terminology
Knowledge of ICH Good Clinical Practice (GCP), and other ICH guidelines related to clinical safety management and documentation.
Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational products
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
High degree of accuracy with attention to details
Willing and able to learn quickly in a fast-paced environment
Good communication skills & excellent team player. Express different viewpoints with colleagues in a proper and constructive manner.
Clinical Research Physician
The Clinical Research Physician will take core medical role as scientific leader in drug development and/or new product launch medical affairs.
The primary responsibility of the CRP is to provide expert medical expertise to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company.
The CRP responsibility includes development the strategic medical plan for to be launched new compound, providing medical expertise for marketing, regulatory affairs etc.
The CRP is responsible for leading in local scientific data generation and dissemination in the planning, designing and conduct of phase 1-4 studies.
Develop medical strategies to support brand launch and life cycle plans for drugs.
Plan and set up medical symposia, advisory board meetings, and/or the facilitation of other meetings with health care professionals.
Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community
Participate in development of scientific data disclosure, data analyses, and final reports and data presentation.
Medical leadership in preparation and administration of the medical budget.
Collaborate proactively and productively with all business, and cross functional partners. Model the leadership behaviors.
Compliance: CRP should ensure all medical related activities in compliance and provide medical governance for business related activities.
Medical Doctor Degree of Oncology
At least 3-5 years of clinical or pharmaceutical medical function experience
Demonstrated ability to balance scientific priorities with business priorities·
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Fluent in English, verbal and written communication.