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Date:  Jan 10, 2023
Location: 

Seoul (KOR), KR

Job Type:  Long-term/regular

Responsibilities

Regulatory

  • Drug product registration/ product variation applications.
  • Follow up amendments related to MA license variation
  • Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders
  • Maintain / manage registration files and RA databases in shared drive of RA.
  • Proof reading product package label against approved label and the labeling regulatory requirement.
  • Communication with regulatory authorities and company headquarters.
  • Submission of drug reimbursement application to HIRA or MoWH.
  • Support drug reimbursement project.
  • Promotional material (e.g., product brochure) review against regulations and product approved label.
  • If required, answer/fulfill requests / queries originating from local authorities(MFDS, MOHW, KPIS, and HIRA etc.)

 

Pharmacovigilance

  • Handling of drug safety related information and report it to HQ and local authority –Serious adverse events from studies and spontaneous adverse events occurred from products
  • Report monthly reconciliation with MIS & Quality complaints
  • Provide PV training to relevant stakeholders
  • Fulfill the required tasks according to local & global procedure and regulations.
  • Management of local PV SOPs
  • Ensure a scientific and regulatory intelligence related to Pharmacovigilance.
  • Learn HQ PV system & procedures and assess/ implement it to local SOPs & procedures.
  •  Fulfill MFDS PV inspection
  • To be registered to MFDS as PV responsible pharmacist.

 

Educations & Experiences

  • Qualification of pharmacist in Bachelor or Higher degree.  

  • 5-7 years’ experience in RA and/or PV in pharmaceutical company

 

Skills & Qualifications

  • Proficient in MS Office, including Word, Excel and PowerPoint

  • Effective communication and interpersonal skills

  • Good verbal and writing English skill is preferred

  • Knowledge of pharmaceutical regulations