NFT Consult Officer Pharmacovigilance Jobs in Kenya
Job Summary
The Officer Pharmacovigilance will work closely with other product safety personnel to ensure the conduct of pharmacovigilance activities and maintenance of a quality-assured pharmacovigilance system.
The role ensures compliance with pharmacovigilance obligations in line with applicable national laws, regulations, guidelines, industry codes, and internal compliance policies and procedures.
Key Responsibilities
Collect, process, document, report, and follow up adverse event reports from all sources.
Translate, transcribe, and accurately enter data from source documents into local safety databases in a timely and consistent manner.
Manage and maintain all relevant local patient safety databases.
Prepare, submit, and distribute aggregate safety reports such as PBRERs and PSURs to Local Health Authorities (LHAs) and partners.
Develop, update, and implement local pharmacovigilance procedures to ensure compliance with global policies and national regulatory requirements.
Collaborate with Medical Affairs, Marketing, Sales, Quality Assurance, and other departments to ensure all potential safety-reporting sources are monitored.
Manage pharmacovigilance clauses in vigilance agreements and ensure compliance with contractual obligations.
Perform reconciliations with Medical Information, Quality Assurance, and third-party contractors for potential adverse events arising from medical inquiries, product complaints, and other sources.
Ensure local and global literature screening activities are conducted as appropriate.
Prepare and submit KPI compliance reports, identify root causes of reporting delays, and implement corrective and preventive actions where required.
Develop
and update pharmacovigilance training materials and conduct adverse event reporting training for relevant teams, field force personnel, and third-party contractors.
Participate in pharmacovigilance internal audits, regulatory authority inspections, and implementation of CAPA plans.
Serve as Deputy QPPV for Kenya and Rwanda.
Perform any other agreed duties assigned by management.
Qualifications
Education
Bachelor of Pharmacy Degree.
Experience
Minimum of 3 years' hands-on experience in Pharmacovigilance or Product Safety.
Skills and Competencies
Meticulous attention to detail and strong analytical thinking skills.
Strong medical and regulatory communication skills.
Familiarity with global drug safety guidelines, including ICH E2E, E2C, and E2D.
Strong report-writing and report-reviewing capabilities.
Effective cross-functional collaboration skills.
Ability to train and support teams on pharmacovigilance requirements and adverse event reporting processes.
How to apply
For more information and job application details, see; NFT Consult Officer Pharmacovigilance Jobs in Kenya
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