Vacancies at NFT Consult

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 so as to comply with pharmacovigilance obligations as per applicable national laws, regulations, guidelines,  industry codes and internal compliance policies and procedures.

Key Responsibilities

• Collection, processing, documentation, reporting and follow-up of adverse event reports from all sources.
• Translate, Transcribe and enter data from source documents into local safety database accurately, consistently and timely.
• Management and maintenance of all relevant local Patient Safety databases
• Preparation/submission/distribution of aggregate safety reports (e.g.PBRER/PSUR) to Local Health Authorities (LHA) and/or partners.
• Develop, update, and implement local pharmacovigilance procedures to ensure compliance with global Aspen policies and national requirements.
• Interacting and collaborating with other departments (such as Medical Affairs, Marketing, Sales, Quality Assurance etc.) to ensure that all sources of safety reports are monitored.
• Management of pharmacovigilance clauses in pharmacovigilance agreements as well as ensuring compliance with the commitments in the vigilance contracts/ agreements.
• Performing reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Ensuring that relevant local /Global literature screening is carried out as appropriate.
• Preparing and submitting KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as required.
• Develop and update training materials for pharmacovigilance and ensure training on AE reporting is carried out to appropriate teams including field force and third-party contractors, as applicable.
• Participating in Pharmacovigilance internal audits, Competent Regulatory Authority inspections and implementation of the respective CAPA plans.
• Deputy QPPV for Kenya and Rwanda
• Any other agreed duty.

Qualifications

Required Qualifications:

 Education:

• Bachelor of Pharmacy degree.

Experience:

•  Over 3 year or more of hands-on experience in Pharmacovigilance/Product safety.

Skills and Competencies:

• Meticulous attention to detail, analytical thinking, strong medical communication, and familiarity with global drug safety guidelines (ICH E2E, E2C, E2D).
• Report writing; – strong report writing and reviewing skills.
• Cross-Functional Collaboration & Training – Effective communication skills and ability to train teams.

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Job Summary

The Officer Regulatory Affairs will be required to support the company by shaping regulatory strategy and ensuring medicines are approved, compliant, and sustainable on the market. This involves acting as a bridge between the company and health authorities, translating regulatory requirements into practical action across the entire product lifecycle, securing and maintaining regulatory approvals and ensuring ongoing compliance with regional and global requirements.

Key Responsibilities

• Product Lifecycle Management: preparing and submitting applications for marketing authorisations (product licenses), responding to queries from regulators and contributing to negotiations where needed, managing post-approval changes, renewals, and variations to maintain product compliance in the market.
• Regulatory Submissions & Strategy: participating in developing regulatory strategies that align with business objectives and scientific goals as well as advising the company and partners on regulatory pathway optimization to accelerate time-to-market.
• Compliance management: Ensuring products meet Local and international regulatory requirements for the markets where they will be supplied.
• Gather, collate and critically evaluate scientific and technical data to support regulatory submissions as well as managing response strategies for regulatory queries and requests for additional information.
• Manage regulatory timelines, track milestones/commitments and coordinate input from departments such as research and development (R&D), clinical, quality and manufacturing
• Regulatory authority interactions; Maintaining productive relationships with regulatory authorities and other partners.
• Labeling and Advertising Review: Review and approval of artworks, packaging, labels, and promotional materials.
• Regulatory Intelligence: Staying updated on evolving regulations in the pharmaceutical industry and advising internal teams on regulatory impact.
• Ensuring proper record keeping, documentation and tracking of regulatory activities as per internal quality management system.
• Advise and participate in quality management system reviews eg Standard Operating Procedures (SOP) and Policy reviews.
• Any other duty as may be assigned by the management.

Qualifications

Required Qualifications:

Education:

• Bachelor of Science in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.

Experience:

•  3 years or more of hands-on experience in regulatory affairs.

Skills and Competencies:

• Familiarity with Good Manufacturing Practice (GMP), Common Technical Document (CTD) formats, and local/international health products and technologies guidelines.
• Analytical & Organizational Skills – Strong problem-solving skills and meticulous attention to detail.
• Report writing; – strong report writing and reviewing skills.
• Cross-Functional Collaboration & Training – Effective communication skills and ability to train teams.