Qualified Person for Pharmacovigilance (QPPV) at Cosmos Limited in Nairobi, Kenya

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    Qualified Person for Pharmacovigilance (QPPV)

    Cosmos LimitedNairobi, Kenya

    Posted

    3 days ago

    Apply by

    26 Aug

    Full Time
    On Site
    Mid
    Healthcare, Medical & Pharmaceutical
    Healthcare & Medical

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    Job Description

    We are seeking a highly motivated and experienced Qualified Person for Pharmacovigilance (QPPV) to oversee and maintain the company's Pharmacovigilance system, ensuring compliance with applicable regulatory requirements and industry standards. The successful candidate will act as the primary contact for product safety matters, manage adverse event reporting, support regulatory inspections and audits, and ensure the continued safety and quality of marketed pharmaceutical products.

    Key Responsibilities

    • Establish, maintain, and oversee the Pharmacovigilance System, including SOPs, training, CAPAs, audits, inspections, and Pharmacovigilance documentation.
    • Ensure timely collection, assessment, reporting, and maintenance of adverse drug reactions (ADRs) and product quality complaints.
    • Lead signal detection, evaluation, and risk management activities.
    • Prepare, review, and submit regulatory safety reports, including Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs), and post-marketing safety evaluations, ensuring compliance with regulatory requirements and reporting timelines.
    • Lead and coordinate Pharmacovigilance inspections and regulatory audits.
    • Conduct Pharmacovigilance training for employees and other relevant stakeholders.

    Required Qualifications

    • Bachelor's Degree in Pharmacy.
    • Certificate in Pharmacovigilance.
    • Registered Pharmacist with the Pharmacy and Poisons Board Kenya.
    • Minimum of 2 years' experience in Pharmacovigilance, Regulatory Affairs, Quality Assurance, or a related pharmaceutical field.
    • Experience within the pharmaceutical industry will be an added advantage.

    Job Details

    Job Function

    Healthcare & Medical

    Minimum Experience

    2 years

    Education Level

    Bachelor’s Degree

    Area of Study

    Pharmacy

    Field of Study

    Pharmacy

    Languages

    English

    Additional Information

    How to Apply: Send your application, including a detailed CV and cover letter, to recruitment@cosmos-pharm.com. Only shortlisted candidates will be contacted.

    Master the Pharmacovigilance Interview: Show Regulatory Precision

    Pharmacovigilance roles demand meticulous attention to regulatory timelines and documentation. Hiring managers will probe your hands-on experience with ICSRs, PSURs, and inspections. Prepare to demonstrate your ability to manage safety data with precision and communicate effectively with regulators.

    1. Quantify your PV experience: On your CV, list specific numbers: how many ICSRs you processed monthly, how many PSURs you authored, and how many audits you passed. Concrete metrics show you can handle the volume and pace of a busy PV unit.

    2. Know the Kenyan regulatory landscape: Be ready to discuss the Pharmacy and Poisons Board requirements and any recent updates in local pharmacovigilance guidelines. Mentioning specific regulations shows you are current and compliant.

    3. Prepare for scenario questions: Expect questions like 'A serious ADR is reported on a Friday evening – walk me through your process.' Practice your response, covering triage, assessment, reporting timelines, and communication with the relevant authorities.

    4. Show your SOP mindset: Emphasize your ability to write, review, and follow Standard Operating Procedures. Bring an example of an SOP you improved or developed, and explain the impact on compliance.

    5. Highlight your training skills: Since the role includes training staff, prepare to describe a time you trained colleagues on PV topics. Show how you made complex regulations understandable and how you measured training effectiveness.

    6. Discuss signal detection experience: If you have used tools like EudraVigilance or WHO VigiFlow, mention them. Talk about a specific signal you detected and how you evaluated it, including the data sources and statistical methods used.

    7. Emphasize your attention to detail: In PV, a single missing data point can cause a compliance issue. Share an example where your meticulous review caught an error before submission, and explain the consequence had it gone unnoticed.

    8. Show your commitment to patient safety: Connect your work to the ultimate goal: protecting patients. Share a story where your vigilance directly improved patient outcomes or prevented a safety issue, demonstrating your passion for the field.

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    Tags

    pharmacovigilance
    regulatory affairs
    adverse drug reactions
    signal detection
    risk management