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.

• 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.

• Meticulous attention to detail
• analytical thinking
• strong medical communication
• 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
• ability to train teams

• Bachelor of Pharmacy degree.