【Consumer】Japan Safety Lead (Manager)

EDUCATION &EXPERIENCE REQUIREMENTS:

Medical pharmacy or life-sciencesdegree with honors / Ph.D (or equivalent)

6-8 years of experience in PVessential; experience working in the pharmaceutical industry is stronglypreferred

Strong people management andleadership compatibilities

Ability to build benchmarkorganizational capabilities

Ability to work independently butcollaboratively in a matrix organization

Extensive experience in conductingtraining

Experience using global safetydatabase desirable

Excellent written and spokencommunication and presentation skills

Effective decision maker with theability to assess impact of actions taken locally on the global PV system

Fluency in written and oral English inorder to facilitate communications with OCMS regional Medical other global

functionsand Health Authority

Strong commitment to compliance withthe relevant rules and procedures and to scientific quality and integrity

Sound judgment strong planning andorganizational skills and the ability to get things done

Strong influencing skills with theability to explain and defend a position which is in the best interests ofpatient safety

Builds and maintains strong relationships with non-PVcolleagues (e.g. Medical Information Regulatory Affairs Commercial)

Learns fast grasps the essence and can changecourse quickly where indicated

Raises the bar and motivates others to a higher standard ofperformance

Creates a learning environment open to suggestions forimprovement

Embraces the ideas of others nurtures innovation andmanages innovation to reality

Focused on compliance; identifies manages and escalatesissues in a timely manner

Reacts quickly and effectively in a fast paced dynamicenvironment

Ability to establish clear direction give and receiveconstructive feedback and bring out the best in people

POSITIONSUMMARY:

Fulfilthe responsibility for the coordination and execution of all Pharmacovigilance(PV) activities across the Consumer sector to ensure that all of Johnson &Johnsons statutory and ethical responsibilities are met. Act as the LocalOperating Company (LOC)s main contact point (GVP manager) for PV matters withthe local Health Authority and Office of Consumer Medical Safety (OCMS).Provide strategic leadership and support LOC to meet all global and local PVresponsibilities.

The Japan SafetyLead will:

Oversee Consumer product safetystrategy and pharmacovigilance (PV) operations in Japan while maintaininghighest level of compliance with local regulations and JNJ global policies.

Build strong networks andcollaborations with safety colleagues in the region

Represent Consumer safety strategicand operational interests in Japan and serve as a key interface between globalfunctions regional leadership and the local operating companies (LOCs).

Ensure responsibilities outlined inthe Service Level Agreements between Consumer safety organizations and the LOCsare mutually fulfilled with respect to product safety accountabilities.

Oversee Consumer medical safetyoperational centers in the country.

Contribute to inspection readiness andtraining related to Consumer safety policies and procedures.

Participate in product safety issuemanagement with local and regional leaders

PRINCIPALRESPONSIBILITIES:

Oversight of the full cross sectorproduct portfolio and link with local management and key stakeholders

Maintain oversight of all required PVregulatory reporting compliance in a timely manner.

Advise the business on the PV impactof local organized data collection programs.

Escalate compliance issues in a timelymanner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriatemitigation is implemented.

Monitor and forecast PV workload toidentify mitigate and escalate potential PV resource and non-complianceissues.

Identify periods of high PV workloadand manage PV resource appropriately to address them.

Support and lead process improvementsto optimize the PV system and make best use of PV resource.

Work collaboratively with regionalaffiliates to ensure consistency of approach across groups.

Build and maintain effective businessrelationships across the LOC to support the implementation of safety standards.

Provide high quality and consistentinput to development of local safety initiatives and programs.

Plan and deploy skilled resourcesagainst project priorities if applicable

Maintain an environment of continuousimprovement within the PV team and contribute to continuous improvementinitiatives across the region and globally with GMS and OCMS.

Case processing & HAreporting

Ensure that local processesprocedures and systems are in place for tracking processing and conductingfollow up for Adverse Events (AE) and other safety information reportable toGMS and OCMS from spontaneous and solicited sources.

Ensure comprehensive data collectionand follow-up to obtain additional information relevant to the case asnecessary to provide a complete description of the safety event.

Ensure local medical or scientificliterature not included in global literature review are reviewed to identifypossible adverse events or special situations reportable to GMS and OCMS andthat any reports are forwarded in a timely manner to GMS and OCMS.

Implement an appropriate local qualitycontrol (QC) procedure to ensure quality of information entered in cases sentto GMS and OCMS and of reporting decisions to local Health Authority.

Ensure a local process is in place forperiodic quality control (QC) sampling of records without AEs for AEidentification as applicable (e.g. product quality complaints (AEPQCs) medicalenquiries partner / vendors etc.).

Ensure that patient confidentialityand privacy in accordance with local applicable laws and regulations areadhered to and if necessary performed by redaction of patient information.

Ensure a local process is in place toforward AEPQCs to Business Quality (BQ) within 24 hours of receipt by PV.

Ensure AEPQCs are reviewed for AEscomplete AE reconciliation and ensure any AEPQCs identified are forwarded to BQ

Ensure compliance with the CAPAprocess for the reporting and investigation of exceptions (nonconformancepotential nonconformance and planned deviations).

Ensure a local tracking system is inplace to ensure timely submissions of adverse events (AEs) to GMS.

Ensure reporting of both clinical andpost-marketing individual case safety reports (ICSRs) and periodic reports tothe regulatory authority as required (and ethics committee if applicable).

Report monthly compliance metrics andinformation to QPPV Office GMS International PV Compliance Strategy and Analytics(CSA) and BQ within the required timelines

Maintain awareness of localpost-marketing and clinical PV legislation and guidelines

Ensure Line Manager/ASPAC Cross SectorSafety Head and PV Policy Group are promptly notified of any changes to relevantlocal legislation.

Ensure formal documentation andnotification to PV Policy Group of local reporting requirements for both ICSRsand aggregate reports provide updates to these requirements per changes inlocal legislation and review and confirm these requirements at least annually.

Coordinate affiliate review andsubmission of PSURs & DSURs.

Ensure any changes to affiliate safetypersonnel are communicated to the Health Authority (i.e. nominated contactperson for PV) GMS OCMS and IPV in a timely fashion.

Complete AE reconciliation withinteracting departments and/or partner companies (if applicable) and act uponany discrepancies

Review and confirms regulatoryreporting requirements at least bi-annually

Ensure local processes and proceduresare in place to clearly define PV responsibilities within the affiliate in linewith global SOPs and local regulations.

Ensure all local PV quality documentsare reviewed and updated as applicable at minimum every 3 years.

Ensure all required documents relatedto PV departmental activities are retained according to SOPs and regulatoryrequirements.

Review any changes to global qualitydocuments and perform and track impact assessment on local quality documents;implement change management in a timely manner according to globalrequirements.

Maintain compliance with localagreements including reconciliation between partner companies and vendors.

Ensure the content of local PVA andother PV agreements conforms to J&J standards per global and localrequirements.

Submit all local PVAs to PV Legal forreview prior to finalization.

Submit all other local PV agreementsto PV Legal for review prior to finalization if these agreements containvariations from the PV agreement language templates.

Responsible for requesting orproviding a copy of all AE files for local product acquisition anddivestitures.

Submit all approved local PVagreements in the PV agreements database for central tracking.

Ensure any changes to local PVagreements (e.g. changes in contact information; terminations) are updated inthe PV agreements database

Responsible for maintaining theinventory of local PV agreements and their respective product list and statuswithin the PV Agreements Database

Maintain the inventory of all local PVagreements within the PV agreements database including current status and alist of applicable products.

Ensure a local tracking system is inplace to monitor compliance with local safety data exchange timeframes.

At a minimum quarterly reconcilelocal PV agreements with the PV agreements database (e.g. InternationalContracts Database) and complete an attestation documenting this review in thePV agreements database.

Maintain and update inventory of alllocal PV agreements within the PSMF including current status and list ofapplicable products

ResearchRelated Activities (RRA)

Ensure that all RRA programs areassessed for impact to AE generation and PV requirements are in place and inline with global and local SOPs.

Ensure that any new programs or anysignificant changes in existing programs are tracked and updated in the Johnsonand Johnson Activity Repository and HIVE inventory.

Ensure training on PV obligations isconducted for all J&J and service provider staff involved in RRA programswith annual refresher training.

Monitor the service provider to ensurePV obligations are being fulfilled including appropriate collection follow upand reconciliation of safety information according to local procedures.

Oversee vendor quality assessments ofrelevant service providers are performed.

Ensure that proposed audits of RRAprogram service providers/vendors are communicated to relevant stakeholdersprior to audit.

Support local BQ to conduct vendoraudits and complete vendor Corrective Action Plans (CAPAs).

Maintain and update inventory of alllocal RRA within the PSMF including current status and list of applicable products

Collaborate with Regulatory Affairs toforward any safety-related inquiry or relevant communication from the local RAto the appropriate global and regional groups as appropriate. Collaborate withappropriate departments to identify the resources and expertise needed toaddress the question. This may include local regional and/or global expertise.

Collaboration with Medical Affairs forthe review and approval of safety aspects of local study protocols to ensureappropriate safety reporting to GMS or appropriate case management center andHealth Authority as required.

Where applicable support theQualified Person Pharmacovigilance (QPPV) to provide safety-related regulatorycommunication (e.g. response to request for information from local HealthAuthority including the provision of information about the volume of sales orprescription as appropriate.

Participate in the Product IssueManagement teams as appropriate.

Provide technical and strategic inputand participate in projects led by the regional GMS team and GMS work streams.

Training

Maintain a version-controlled trainingmatrix/plan for local PV personnel which includes but is not limited to localSOPs local regulations and references to the global affiliate PV coursesallocated in Compliance Wire (CW) and SUMMIT.

Ensure training compliance with GMSOCMS and local PV training requirements and other mandatory training asrequired by GMS and OCMS.

Ensure all Affiliate employees andcontractors for all countries the LSO s responsible for (including Global orRegional staff based at the LOC) are aware of their responsibility to completeannual adverse event identification and reporting training. This PV training isto be undertaken at least annually and appropriate training records shall bemaintained. Ensure this training is completed.

Ensure that any training of partnercompany and vendor staff is completed according to local contract requirementsand appropriately documented.

RiskManagement

Have an appropriate system of and RiskManagement in place in order to assure appropriate oversight for productswithin its responsibility

Review and complete country specificAnnex as required according to local requirements if applicable

Collaborate with Medical Affairs andRegulatory Affairs team to ensure that RMP activities are completed on a timelymanner

Ensure implementation and tracking ofRMP activities are in place including documentation of completed activities

Review all risk management plans andPSURs to obtain information on the risk/benefit profile of products

Monitor the risk/benefit profile oflocal products and communicate changes or safety issue/concerns to the APACCross Sector Safety Team Lead and the QPPV (for products marketed in the EMEA)for evaluation.

Audit & inspectionreadiness

Lead the audit / inspectionpreparations for internal PV audits Johnson & Johnson RegulatoryCompliance (JJRC) and Bioresearch Quality & Compliance (BRQC) inspections.

Act as the key affiliate contact forall PV audits.

Lead the review of documents prior toand during PV audits and inspections.

Ensure that any Health Authoritycommunications are forwarded to the required PV personnel and that anyresponses/corrective actions are tracked and completed according to schedule.

Ensure PV inspection readiness at theaffiliate level at all times.

Ensure that a process is in place forreporting of AEs after hours and testing is documented as per Global andRegional requirements

Ensure that a disaster recovery/business continuity plan is established in a risk-based manner to allow forcontinuation of critical business processes for PV

Filing& archiving

File all source documents and othersafety-related documents according

Archive documents periodically asnecessary

DECISION-MAKINGAND PROBLEM-SOLVING:

Inscope of the above mentioned responsibilities in line with local healthauthority regulations.

Independentand collaborative decision making with internal and external business

partnersincluding R&D medical affairs and other safety colleagues in subjectmatters including cluster

productsafety strategy PV operations issue management and process excellence.

Implementsand monitors regional strategy in conjunction with business partners. Resolvesissues with

partnersrelating to compliance and performance of Service Level Agreements.

Identifiesmethods of consistently improving cost-effectiveness of cluster activities insupport of LOCs.

REPORTINGRELATIONSHIPS:

CountrySafety Lead is an employee of the Global Medical Safety Organization.

TheCountry Safety Lead has a reporting line into the Vice President QualifiedPerson Pharmacovigilance and International Pharmacovigilance via the AreaSafety Lead and ASPAC Cross Sector Safety Head.

TheJapan Safety Lead reports directly to the IPV ASPAC Cross-sector Safety Head.

WORKINGRELATIONSHIPS/INTERFACES:

All LOC employees

Medical Information

Business Quality

Sales & Marketing

Regulatory Affairs

Medical Affairs

OCMS

International Pharmacovigilance

BRQC

GMS

Health Authorities

License partners

Market research agencies

3 party vendors

Healthcare professionals

Industry colleagues