Officer Pharmacovigilance

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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Minimum qualifications

BA/BSc/HND

How to apply

Use the link(s) below to apply on company website.

Officer Pharmacovigilance

Officer Regulatory Affairs

https://www.myjobmag.co.ke/apply-now/1374887

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