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Manager, Medical Safety
Requisition ID: 1805645714W
• Fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson’s statutory and ethical responsibilities are met.
• Act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for PV matters with the local Health Authority, Global Medical Organisation (GMO), Global Medical Safety (GMS) and Office of Consumer Medical Safety (OCMS).
• Provide strategic leadership and support LOC to meet all global and local PV responsibilities.
Oversight of the PV System
• Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
• Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
• Advise the business on the PV impact of local organized data collection programs.
• 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 PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
• Identify periods of high PV workload and manage PV resource appropriately to address them.
• Support and lead process improvements to optimize the PV system and make best use of PV resource.
• Work collaboratively with regional affiliates to ensure consistency of approach across groups.
• Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
• 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 PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.
Case processing & HA reporting
• Ensure that local processes, procedures and systems are in place for tracking, processing, and conducting follow up for Adverse Events (AE) and other safety information reportable to GMS and OCMS from spontaneous, and solicited sources.
• Ensure comprehensive data collection and follow-up to obtain additional information relevant to the case as necessary to provide a complete description of the safety event.
• Ensure local medical or scientific literature, not included in global literature review, are reviewed to identify possible adverse events or special situations reportable to GMS and OCMS, and that any reports are forwarded in a timely manner to GMS and OCMS.
• Implement an appropriate local quality control (QC) procedure to ensure quality of information entered in cases sent to GMS and OCMS and of reporting decisions to local Health Authority.
• Ensure a local process is in place for periodic quality control (QC) sampling of records without AEs for AE identification as applicable (e.g. product quality complaints (AEPQCs), medical enquiries, partner / vendors etc.).
• Ensure that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information.
• Ensure a local process is in place to forward AEPQCs to Business Quality (BQ) within 24 hours of receipt by PV.
• Ensure AEPQCs are reviewed for AEs, complete AE reconciliation and ensure any AEPQCs identified are forwarded to BQ
• Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
• Ensure a local tracking system is in place to ensure timely submissions of adverse events (AEs) to GMS.
• Ensure reporting of both clinical and post-marketing individual case safety reports (ICSRs) and periodic reports to the regulatory authority as required (and ethics committee, if applicable).
• Report monthly compliance metrics and information to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines
• Maintain awareness of local post-marketing and clinical PV legislation and guidelines
• Ensure Line Manager/APAC Cross Sector Safety Lead, and PV Policy Group are promptly notified of any changes to relevant local legislation.
• Ensure formal documentation and notification to PV Policy Group of local reporting requirements for both ICSRs and aggregate reports, provide updates to these requirements per changes in local legislation, and review and confirm these requirements at least annually.
• Coordinate affiliate review and submission of PSURs & DSURs.
• Ensure any changes to affiliate safety personnel are communicated to the Health Authority (i.e. nominated contact person for PV), GMS, OCMS and IPV in a timely fashion.
• Complete AE reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies
• Review and confirms regulatory reporting requirements at least bi-annually
Processes & procedures –
• Ensure local processes and procedures are in place to clearly define PV responsibilities within the affiliate in line with global SOPs and local regulations.
• Ensure all local PV quality documents are reviewed and updated as applicable at minimum every 3 years.
• Ensure all required documents related to PV 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.
• Maintain compliance with local agreements, including reconciliation between partner companies and vendors.
• Ensure the content of local PVA and other PV agreements conforms to J&J standards per global and local requirements.
• Submit all local PVAs to PV Legal for review prior to finalization.
• Submit all other local PV agreements to PV Legal for review prior to finalization if these agreements contain variations from the PV agreement language templates.
• Responsible for requesting or providing a copy of all AE files for local product acquisition and divestitures.
• Submit all approved local PV agreements in the PV agreements database for central tracking.
• Ensure any changes to local PV agreements (e.g. changes in contact information; terminations) are updated in the PV agreements database
• Responsible for maintaining the inventory of local PV agreements and their respective product list and status within the PV Agreements Database
• Maintain the inventory of all local PV agreements within the PV agreements database, including current status and a list of applicable products.
• Ensure a local tracking system is in place to monitor compliance with local safety data exchange timeframes.
• At a minimum quarterly, reconcile local PV agreements with the PV agreements database (e.g. International Contracts Database), and complete an attestation documenting this review in the PV agreements database.
• Maintain and update inventory of all local PV agreements within the PSMF, including current status and list of applicable products
Research Related Activities (RRA)
• 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.
• Ensure that any new programs or any significant changes in existing programs are tracked and updated in the Trial Master Source (TMS) and HIVE inventory.
• Ensure training on PV obligations is conducted for all J&J and service provider staff involved in RRA programs with annual refresher training.
• Monitor the service provider to ensure PV obligations are being fulfilled, including appropriate collection, follow up and reconciliation of safety information according to local procedures.
• Oversee vendor quality assessments of relevant service providers are performed.
• Ensure that proposed audits of RRA program service providers/vendors are communicated to relevant stakeholders prior to audit.
• Support local BQ to conduct vendor audits and complete vendor Corrective Action Plans (CAPAs).
• Maintain and update inventory of all local RRA within the PSMF, including current status and list of applicable products
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.
• 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 centre and Health Authority, as required.
• Where applicable, support the Qualified Person Pharmacovigilance (QPPV) 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.
• Provide technical and strategic input and participate in projects led by the regional GMS team and GMS work streams.
• 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.
• Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO.
• Ensure all Affiliate employees and contractors for all countries the LSO s responsible for (including Global or Regional staff based at the LOC) are aware of their responsibility to complete annual adverse event identification and reporting training. This PV training is to be undertaken at least annually, and appropriate training records shall be maintained. Ensure this training is completed.
• Ensure that any training of partner company and vendor staff is completed according to local contract requirements, and appropriately documented.
Risk Management –
• 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.
Audit & inspection readiness –
• Lead the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
• Act as the key affiliate contact for all PV audits.
• Lead the review of 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 affiliate level at all times.
• Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements
• Ensure that a disaster recovery /business continuity plan is established in a risk-based manner to allow for continuation of critical business processes for PV
Filing & archiving
• File all source documents and other safety-related documents according
to local and global requirements
• Archive documents periodically as necessary
• Bachelor’s degree in appropriate scientific or business discipline is preferred
• 7-10 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
• Must have a working knowledge of the clinical payment processing with 4 years of payment experience
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is preferred
• Ability to work effectively in cross functional teams
• Strong and proven analytical and problem resolution skills
• Ability to demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
• Previous experience working in virtual teams preferred
• Able to reason both abstractly/conceptually as well as practically
• Able to operate both at the local level and globally and connect easily at various levels in the organization.
• Possess strong teaming skills (collaboration, communication, knowledge sharing …) and have a result oriented personality with strong focus on quality of work. Previous experience working in virtual teams preferred
• Working knowledge of PCs (MS Office suite at a minimum), Sharepoint, intermediate presentation skills
• Excellent communication skills (both oral and written)
• Good knowledge of English, both verbally and written
• Willingness and ability to travel (international) – about 10-15%
Xian-Janssen Pharmaceutical Ltd. (7043)
Drug & Product Safety Science