Johnson & Johnson Careers

Medical safety senior specialist

Beijing, China; Beijing, China
Drug & Product Safety Operations

Job Description

Requisition ID: 1805682926W

• Support local management to ensure that company procedures as well as external guidelines and regulations are implemented within China and adhered to
• Prepare and maintain the operations metrics for China Medical Safety
• To assist management in the development and maintenance of relevant PV SOPs and guidance documents
• Participate in other projects and cross-functional teams as per the discretion of the China Cross Sector Safety management / delegate
• Support• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
• Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to global medical safety (GMS) or appropriate case management centre and Health Authority, as required.
• Where applicable, support the Qualified Person Pharmacovigilance (QPPV) or equivalent to provide safety-related regulatory communication (e.g., response to request for information from local Health Authority, including the provision of information about the volume of sales or prescription, as appropriate.
• Participate in the Product Issue Management teams, as appropriate. promotional material and local label review in line with local procedures, guidelines and regulations
• Other duties, tasks as assigned
• Have an appropriate system of and Risk Management in place in order to assure appropriate oversight for products within its responsibility
• Review and complete country specific Annex as required according to local requirements, if applicable
• Collaborate with Medical Affairs and Regulatory Affairs team to ensure that risk management plan (RMP) activities are completed on a timely manner
• Ensure implementation and tracking of RMP activities are in place including documentation of completed activities
• Review all risk management plans and periodic safety update reports/periodic benefit risk evaluation reports (PSURs/PBRERs) to obtain information on the risk/benefit profile of products
• Monitor the risk/benefit profile of local products and communicate changes or safety issue/concerns to the APAC Cross Sector Safety Team Lead, and the QPPV (for products marketed in the EMEA) for evaluation.
• Participate the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
• Act to support management for all PV audits.
• Assist with the review of documents prior to and during PV audits and inspection.
• Ensure that any Health Authority communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.
• Ensure PV inspection readiness at the affiliate level at all times.

• Medical or pharmacy degree or life-sciences with a master’s qualification or above
• Experience working in PV or the pharmaceutical industry is strongly preferred
• Knowledge of PV regulations
• Demonstrated attention to detail
• Excellent written and spoken communication and presentation skills
• Fluency in written and oral English and Chinese in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority
• High customer orientation
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Sound judgment, strong planning and organizational skills, and the ability to get things done
• Demonstrated strong sense of urgency
• Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety
Primary Location
Other Locations
Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function
Drug & Product Safety Operations
Requisition ID