Participate in manufacturing authorization processes of the facility, marketing authorization processes of the finished products, pharmacovigilance processes and support compliance to other regulatory requirements
JOB ROLES AND EXPECTATIONS
- Ensuring implementation of company quality policy.
- Work towards achieving defined quality objectives
- Preparation and submission of dossiers for marketing authorization applications.
- Preparation and submission of additional information as may be requested by regulatory authorities.
- Preparation and submission of variation applications to registered products.
- Preparation and submission of applications for manufacturing Licenses.
- Keeping up to date with changes in regulatory legislation and guidelines.
- Maintaining and monitoring/follow up on registration status of all products country wise.
- Maintaining regulatory compliances to pharmacovigilance requirements.
- Addressing regulatory Authorities related pharmacovigilance queries.
- Execution of pharmacovigilance activities such as Medical Information Call Center (MICC), Individual Case Safety Report (ICSR), Periodic Benefit Risk Evaluation Reports (PBRER), signal detection.
- aggregate reporting, label review and regulatory intelligence activity.
- Ensure Safety Data Exchange Agreements (SDEAs) are signed between partners and Apdl for businesses in Uganda & as appropriate.
- Participate in Pharmacovigilance-inhouse training as applicable
- Preparing and maintaining regulatory documentation.
- Ensure safety of classified information
- Ensure that any other duty assigned by HOD is executed
COMPETENCIES
- Attention to details
- overall good pharmaceutical knowledge,
- endeavor for learning and logical explanation to queries
- Analytical Skills
- Computer Skills (PPt, Excel, MS Word and Adobe Acrobat)
- Intermediate level of English and one other local language preferably Luganda.
- Time management skills
- Problem-solving skills
- Presentation skills
- Communication skills
- Innovative / creative skills
MINIMUM QUALIFICATIONS / REQUIREMENTS
- Honors Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related field.
- At least 2 years of progressive experience, preferably in a busy pharmaceutical or healthcare industry.
APPLICATION PROCESS
Please submit your CV and academic credentials to apdlug.careers@abacuspharma.com by February 17, 2025, at 5:00 PM.
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