Pharmacist managing pharmaceutical manufacturing and import business

• Pharmaceutical manufacturing/import management (production sector, quality sector)

  Pharmaceutical manufacturing/import management work in accordance with the Pharmaceutical Affairs Act of the Republic of Korea and Global GMP regulations

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PURPOSE

• To assist in maintaining government approval for drugs

  Identify the correct value of products based on scientific evidence. This role involves communicating, delivering, and exchanging this information with customers in an objective and scientific manner, thereby embodying true patient centricity.

• Discharge the obligation as quality responsible person

• Manage and operate the QMS, oversees compliance with the QA (Quality agreement) and discharge responsibilities of that QCTC  (Quality Control Training Course) officer

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JOB-HOLDER REQUIREMENTS

A pharmacist required with at least 5 years of experience in pharmaceutical industry

KEY ACCOUNTABILITIES

RA

• • Market Authorization (MA) maintenance: MA variation (including pre-review), MA immediate report, MA renewal.

    K-DMF maintenance: DMF Registration(filing) change, DMF Annual report

  • Maintenance of Foreign manufacturing site registration

  • Foreign manufacturing site registration/change

• • • Annual report

    • Maintenance of Import business license: Variation of Import business license

• • Maintenance of ID code registration

  • Artwork review

  • Interpretation and consultation of applicable laws (Pharmaceutical Affairs Act, etc.)

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MSL

• • Contribute to providing optimal therapeutic benefits to patients by objectively and accurately conveying the correct medical value of the product to Medical Thought Leaders (MTL) through communication.

    Collect and share medical insights through interactions with MTL, establish and execute medical strategies based on these insights, in collaboration with relevant departments.

  • Proactively plan and implement Scientific programs (symposiums, advisory meetings, etc.) across the product life cycle in line with the company's vision and strategic direction.

  • Manage clinical research related to the product or disease in accordance with relevant regulations and provide scientific support.

  • Providing medical product overview (basic training) to internal stakeholders
     

MI

• • Medical Information Service

    Ensures that good quality medical information is provided to internal staff and external customer in a timely manner and maintain oversight overall medical information service.

• • • Maintain and oversight overall medical information service process.

    • Perform periodic literature review and update the relevant stakeholders

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• • Promotional Material Review:

    Performs medical review of promotional materials, press release, speaker slides to ensure compliance with "0000/ 0000"  internal SOPs, local regulations and maintain oversight overall promotional material review process.

• • • Archive the produced promotional material to check final material.

    • Medical News Service:

• •         Provide up-to-date or scientific valuable medical information to internal stakeholders.

• • • Cooperation:

• •          Perform medical review to the promotional claims on product package.

• • • Perform medical review of product label.

    • Perform reconciliation with PV team to ensure no discrepancy.

    • Knowledge management:

• • Create, update and cascade Knowledge Management documents to coach, develop, and support MIA members to achieve their potential in their area of expertise, while building additional personal and professional skills to lift the performance of the group as a whole.

• • • To support, (review and approve) document translations English to local language and vice versa