Johnson & Johnson 职业机会
Manager, Medical Safety
Requisition ID: 1905762106W
-Fulfil the responsibility for the coordination and execution of all Medical Safety (MS) activities across the Pharmaceutical and Consumer sectors. Act as one of the Local Operating Company (LOC)’s and assigned territories’ (as applicable) contact point for Medical Safety matters with Global Medical Organisation (GMO), Office of Consumer Medical Safety (OCMS), Global Medical Safety (GMS). Support PV team and LOC stakeholders to meet all global and local MS responsibilities.
-Oversight of MS activities;
Oversight of the assigned cross sector product portfolio, and link with local management and key stakeholders
Maintain oversight of all required MS regulatory reporting compliance in a timely manner e.g RMPs, aggregate reports.
Advise the business on the MS impact of local organized data collection programs, post marketing programs, RWE studies etc.
Escalate compliance issues in a timely manner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
Monitor and forecast MS workload to identify, mitigate and escalate potential MS resource and non-compliance issues.
Identify periods of high MS workload and manage MS resource appropriately to address them.
Support and lead process improvements to optimize MS activities.
Work collaboratively with regional affiliates to ensure consistency of approach across groups.
Build and maintain effective business relationships across the LOC.
Provide high quality and consistent input to development of local safety initiatives and programs.
Plan and deploy skilled resources against project priorities, if applicable
Maintain an environment of continuous improvement within the MS team and contribute to continuous improvement initiatives across the region and globally with GMO, OCMS and GMS.
-Medical-Safety regulatory reporting;
Ensure that local processes, procedures and systems are in place for planning, writing, review and submission of any regulatory required LOC-specific reports
Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
Report compliance metrics and information to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines if required e.g. ARMA implementation, DHCP distribution
Maintain awareness of local post-marketing and clinical PV legislation and guidelines relating to Medical Safety.
Coordinate affiliate review and submission of PSURs & DSURs.
Processes & procedures –
Ensure local processes and procedures are in place to clearly define MS responsibilities within the LOC in line with global SOPs and local regulations.
Ensure all local MS quality documents are reviewed and updated as applicable at minimum every 3 years.
Ensure all required documents related to MS departmental activities are retained according to SOPs and regulatory requirements.
Review any changes to global quality documents and perform and track impact assessment on local quality documents; implement change management in a timely manner according to global requirements.
-Key MS activities;
SUSAR assessment - from a compliance and monitoring perspective – looking for potential signals, risk control plan development (environmental impact on patient safety – site suitability and selection).
Signal detection – ensure LOC complies with any local HA signal-detection requirements, collaborate with regional and global colleagues to signal detection activities and communications.
Intensive monitoring programs including Compassionate Use Program, Patient Access Program, Registries, Post-Marketing Studies – involvement with key stakeholders to ensure the programs meet local, regional or global requirements from a compliance and strategic safety perspective.
Monitor any MS service providers to ensure PV and MS obligations are being fulfilled.
-Collaborate & 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.
Collaborate with compound teams/cross-functional teams in MS relevant areas of product lifecycle management including pre-launch activities, dossier preparation, risk minimisation activity (planning, implementation, evaluation strategy), intensive monitoring programs.
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management center and Health Authority, as required.
Participate in the Product Issue Management teams, as appropriate.
Provide MS related input and participate in projects led by the regional and global MS team.
Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO.
Provide training within the LOC or regionally as required e.g. MS-related training to MAF/MSL
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 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 PSURs 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.
Provide MS input in pre-authorisation phase/submission-planning phase of product lifecycle to guide appropriate planning and management of RMP-related activities.
-Audit & inspection readiness;
Participate in audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
Act as a key affiliate contact for MS related work for all PV audits.
Participate in the review of MS-related documents prior to and during PV audits and inspections.
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 LOC level at all times (for MS-related responsibilities).
Drug & Product Safety Science