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Date: Oct 27, 2017

Location: Korea, Republic of, KR

Company: MSD

Requisition ID: DRU000662

  •     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
    Merck’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 Merck 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 Merck’s
    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.
  •     Author the PMS protocol.
  •    Participate as a core member
    for RMP and conduct the activities assigned to the Global Safety.
  •     Manage the contract related
    activities.

Qualifications

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



·       
Minimum
3 years of pharmaceutical industry experience

(PV/Medical experience preferred)



·       
Functional Knowledge: Awareness
of pharmacovigilance concepts, principles, practice & standards, knowledge
of 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:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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