[Janssen] Medical Safety Specialist

Taipei City - Taiwan

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Experience Skills and Knowledge:

2years of experience in PV/Medical safety related field essential; experienceworking in the pharmaceutical industry is strongly preferred

Experiencein conducting training

Knowledgeof PV regulations

Experienceusing global safety database desirable

Demonstratedattention to detail

Excellentwritten and spoken communication and presentation skills

Effectivedecision maker with the ability to assess impact of actions taken locally onthe global PV system

Fluencyin written and oral English in order to facilitate communications with GMOregional Medical other global functions and Health Authority

Highcustomer orientation

Strongcommitment to compliance with the relevant rules and procedures and toscientific quality and integrity

Soundjudgment strong planning and organizational skills and the ability to getthings done

Demonstratedstrong sense of urgency

Stronginfluencing skills with the ability to explain and defend a position which isin the best interests of patient safety

Description

A global leader in health and personal care with over 125000employees in over 275 companies in 60 countries. We work with partners inhealthcare to touch the lives of more than a billion people every daythroughout the world. Johnson & Johnson companies market leading productsand services in three business segments: Consumer Pharmaceuticals and MedicalDevices.

By caring one person at a time we aspire to help billions ofpeople live longer healthier happier lives.

We have a new and exciting opportunity to hire a Medical SafetySpecialist for our Pharmacovigilance here at Taipei Taiwan office.

Job Purpose and Scope:

Support the Medical Safety Associate Manager to fulfil theresponsibility for the coordination and execution of all Medical Safety (MS)activities across the Pharmaceutical and Consumer sectors. Act as one of theLocal 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 MSresponsibilities.

Core Job Responsibilities:

Medical Safety Specialist - Taiwan:

Support the oversight of MS activities

Support oversight of the assignedcross sector product portfolio and link with local management and keystakeholders

Support to maintain oversight ofall required MS regulatory reporting compliance in a timely manner e.g RMPsaggregate reports.

Advise the business on the MSimpact of local organized data collection programs post marketing programsRWE studies etc.

Escalate compliance issues in atimely manner to Line Manager and North Asia Cross Sector Safety Area Lead toensure appropriate mitigation is implemented.

Monitor and forecast MS workloadto identify mitigate and escalate potential MS resource and non-complianceissues.

Support and lead processimprovements to optimize MS activities.

Workcollaboratively with regional affiliates to ensure consistency of approachacross groups.

Build and maintaineffective business relationships across the LOC.

Provide highquality and consistent input to development of local safety initiatives andprograms.

Support the maintenance of an environment of continuous improvementwithin the MS team and contribute to continuous improvement initiatives acrossthe region and globally with GMO OCMS and GMS.

Key Medical Safety Activities:

Support signal detection ensureLOC complies with any local HA signal-detection requirements collaborate withregional and global colleagues to signal detection activities andcommunications.

Support intensive monitoringprograms including Compassionate Use Program Patient Access ProgramRegistries Post-Marketing Studies involvement with key stakeholders toensure the programs meet local regional or global requirements from acompliance and strategic safety perspective.

Monitor any MS service providersto ensure PV and MS obligations are being fulfilled.

Risk Management:

Have an appropriate system of and Risk Management in place in order toassure appropriate oversight for products within its responsibility

Reviewand complete country specific Annex as required according to localrequirements if applicable

Collaboratewith Medical Affairs and Regulatory Affairs team to ensure that RMP activitiesare completed on a timely manner

Ensureimplementation and tracking of RMP activities are in place includingdocumentation of completed activities

Reviewall risk management plans and PSURs to obtain information on the risk/benefitprofile of products

Monitorthe risk/benefit profile of local products and communicate changes or safetyissue/concerns to the APAC Cross Sector Safety Team Lead and the QPPV (forproducts marketed in the EMEA) for evaluation.

ProvideMS input in pre-authorisation phase/submission-planning phase of productlifecycle to guide appropriate planning and management of RMP-relatedactivities.

Required Experience:

Experience Skills and Knowledge:2years of experience in PV/Medical safety related field essential; experienceworking in the pharmaceutical industry is strongly preferredExperiencein conducting trainingKnowledgeof PV regulationsExperienceusing global safety database desirableDemonstratedattention to ...