PV Contractor Job

Date: May 16, 2019

Location: Jung-gu, 11, KR

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Requisition ID: DRU000976

- Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation  including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per MSD's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.

- Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.

- Responsible for the reconciliation of adverse events reports received from other MSD operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.

- Responsible for the filing, storage and archiving of safety-related data in accordance with MSDs policies and local requirements

- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.

- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.

- Identify and communicate potential safety issues to PV Country Lead.

- Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.

- Complete and document required PV training within the required timelines.

Qualifications

·      Background requirement: Health,life science or medical science degree (pharmacist preferred)


·      Minimum1 years of pharmaceutical industry experience preferred


·      Functional Knowledge: Awarenessof pharmacovigilance concepts, principles, practice & standards, knowledgeof pharmacovigilance regulation and GCP


·      Skills: excellent written &spoken English, communication skill, time management skill, sense of urgency,compliance mindset & computer skill



Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Consulting, Medical, Pharmaceutical Sales, Pharmacovigilance, Pharmaceutical, Service, Healthcare, Sales, Science

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