Johnson & Johnson Careers
Senior Manager, Medical Safety
Requisition ID: 1805647442W
• Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
• Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
• Ensure local processes and procedures are in place to clearly define PV responsibilities within the affiliate in line with global SOPs and local regulations.
• Maintain compliance with local agreements, including reconciliation between partner companies and vendors.
• Ensure that all RRA programs are assessed for impact to AE generation and PV requirements are in place and in line with global and local SOPs.
• 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.
• Maintain a version-controlled training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in ComplianceWire (CW) and SUMMIT.
• Have an appropriate system of and Risk Management in place in order to assure appropriate oversight for products within its responsibility
• Lead the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
• File all source documents and other safety-related documents according
to local and global requirements
• Medical, pharmacy or life-sciences degree (or equivalent)
• 4-5 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
• Extensive experience in conducting training
• Knowledge of PV regulations
• Experience using global safety database desirable
• Demonstrated attention to detail
• Excellent written and spoken communication and presentation skills
• Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
• Fluency in written and oral English 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
Xian-Janssen Pharmaceutical Ltd. (7043)
Drug & Product Safety Science