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PV/ RA ASSISTANT MANAGER [HJ1213-08]

役職名: PV/ RA ASSISTANT MANAGER [HJ1213-08]
雇用形態: Permanent
勤務地: Malaysia
職種:
業種: ヘルスケア/製薬
給与: 7000.00 - 9000.00
Start date: 28 Aug 2020
求人ID: 44873
お問い合わせ情報: How Jing May
お問い合わせ先: jingmay.how@jac-recruitment.com
掲載日: 約1ヶ月 前

JOB RESPONSIBILITIES

  • Manage safety queries and other significant safety information locally, inclusive of crisis management.
  • Prepare, maintain and implement the necessary SOPs that meet the requirements of the regulations with respect to drug safety.
  • Conduct local literature search and ensure any other safety data deemed fit for inclusion in the PSUR/PBRER or signal management process.
  • Review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
  • Continual risk assessment of local PV operations, including early notification of any risks.
  • Responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations and registration renewals.
  • Manage Import License and associated Product List in timely manner to ensure continuous supply of stock.
  • To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.

JOB REQUIREMENTS

  • Degree in Pharmacy (with Pharmacist License).
  • Minimum 5 years or more in PV and RA role in pharmaceutical company.
  • Able to work independently and with others, positive attitude, willingness to embrace new skills.
  • Fluency in English and Bahasa Malaysia (written and spoken).
  • IT: Microsoft Office (PowerPoint, Excel, Word).