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


 



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


 



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.)


 





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


 










Promotional Material Review:
Performs medical review of promotional materials, press release, speaker slides to ensure compliance with Sobi/Handok JV’s 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