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Intern, Regulatory Affairs and QPPV Backup

JOB SUMMARY

Company DKT Internati...
Industry Not-for-profi...
Category Medical/Pharm...
Location Accra
Job Status Full-time
Salary GH¢ 
Education Post-graduate...
Experience 7 years
Job Expires Mar 15, 2019
Contact ...
 

Company Profile

DKT International Inc. is a non-profit organization whose core mission is the provision of safe and affordable options for family planning and HIV/AIDS prevention. DKT operates 24 programs in 25 countries worldwide. 

Job Description

Department: Regulatory Affairs and Pharmacovigilance 

Organization Relationship

  • Directly reports to: Assistant General Manager Regulatory Affairs and QPPV 
  • Directly supervises: N/A

 

Job Summary
The Intern, Regulatory Affairs and Qualified Person for Pharmacovigilance (QPPV) backup  will work closely with the Assistant General Manager, Regulatory Affairs and QPPV and is accountable in the absence of QPPV for the preparation and management of simple and complex regulatory submissions. Act as a backup on all matters relating to pharmacovigilance and safety of the marketed products including pharmacovigilance inspections. Assist in establishing and maintain a system which ensures that information about all suspected adverse drug reaction /event which are reported to the personnel of the marketed authorization holder, including to medical representatives, is collected, processed and evaluated and forwarded to the Authority in line with the time lines stipulated by the authority.  

The incumbent will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external regulatory bodies, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to government regulatory agencies in the absence of the Assistant General Manager regulatory affairs and QPPV. 

Specific Duties and Responsibilities
Reporting to the Assistant General Manager (RA/QPPV), the Intern (RA/Back up QPPV) will: 

  • Actively assist the development of new products and implementation of regulatory strategies for assigned projects. 
  • Assist in the registration of new commodities/drugs with the FDA
  • Timely compile materials for license renewals, updates and registrations of products in the absence of QPPV.
  • Assist in Maintaining regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Assist, Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes and ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival). 
  • Assist in the Preparation  of the  following for submission to the Authority;
    • adverse drug reaction reports
    • Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation reports (PBRER), when necessary
    • company-sponsored pre- and post-registration study reports
    • Risk Management Plan (including Ghana Specific Risk Management Plan) when requested by the Authority
    • Ongoing pharmacovigilance evaluation during the post-registration period.
  • Be a back up to in the absence of QPPV to ensure that any request from the Authority for additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided to the Authority promptly and fully.
  • Assist in overseeing the safety profiles of the company’s marketed products and any emerging safety concerns.

Core Job Responsibilities
Be a backup in the absence of Assistant General Manager (RA/QPPV) to;

  • Represent Regulatory Affairs on DKT product development to ensure all regulatory requirements are met throughout the development process.
  • Complete submissions to FDA and GSA regulatory entities.
  • Create and maintain systems for Adverse Drug Reporting.
  • Review advertising and marketing materials for appropriateness and compliance to regulatory requirements and laws.
  • Implement pharmacovigilance activities
  • Provide input into Risk Management Plan when necessary
  • Prepare and report on regulatory actions to emerging safety concerns (e.g. variations, urgent safety restrictions, and, as appropriate, communication to Patients and Healthcare Professionals)
  • Provide clear backup plans when absent from duty including leave or travel
  • Provide oversight regulatory responsibilities for commodities from manufacturer through warehousing to sales outlets

Abilities

  • Experience with regulatory submissions, including IDNs, and marketing applications in Common Technical Document format, is essential
  • Ability to handle multiple assignments and good judgement in prioritizing tasks
  • Demonstrated ability to work independently and within a group setting, and to interact with various departments and functional groups
  • Ability to push regulatory bodies to meet deadlines (Keeping accurate records of all interactions with regulatory authorities; manufacturers and supplies)
  • Strong communication skills and highly influential, and  the ability to identify and recommend solutions to problems
  • High level of attention to detail, and proficient with Microsoft Office applications, Adobe and Excel

How To Apply

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