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    Lqppv Manager (Local Qualified Person For Pharmacovigilance)

    Pharmalex
    2+ years
    Not Disclosed
    Remote
    10 Dec. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    LQPPV Manager (Local Qualified Person for Pharmacovigilance) - Tunisia (Remote)
    Pharmalex

    Are you ready to take on new challenges and opportunities in a dynamic, fast-paced company? Then Pharmalex is the place for you!

    Pharmalex, now part of Cencora, is a global leader in providing services to the pharmaceutical, biotech, and medical device industries. We specialize in designing effective solutions for regulatory needs at every stage, from early development and market entry to product maintenance.

    We are looking for a Local Qualified Person for Pharmacovigilance (LQPPV) to join our team in Tunisia. This person will be responsible for establishing and maintaining the marketing authorization holder’s local pharmacovigilance system and overseeing local pharmacovigilance operations.

    Your Role

    As the LQPPV Manager, you will:

    • Set up and manage the local pharmacovigilance system in compliance with regulatory requirements.
    • Perform local literature searches and manage local ICSR (Individual Case Safety Report) submissions.
    • Conduct PV intelligence screening and maintain the local PSMF (Pharmacovigilance System Master File).
    • Oversee local organized data collection and manage local Pharmacovigilance Agreements (PVA).
    • Adapt and submit PSUR (Periodic Safety Update Reports) and RMP (Risk Management Plans) locally.
    • Carry out signal detection and implement additional risk minimization measures.
    • Review materials related to local post-authorization safety.
    • Provide integrated first-level Medical Information and PQC (Product Quality Complaints) support.
    • Participate in PV-related audits and inspections.
    • Attend project meetings and provide monthly reports on the status of the local PV system.
    • Ensure PV training for affiliate employees, service providers, and third parties.
    • Act as the primary contact for PV with the Competent Authority in the territory, ensuring 24/7 availability if required by law.
    • Interface between the EU-QPPV/Global PV team and the local regulatory authority.
    • Collaborate closely with the global PV system of the client and other related global and local departments.
    • Develop and maintain pharmacovigilance procedures and SOPs (Standard Operating Procedures) for local tasks.
    • Cooperate with the Deputy LQPPV and provide support in case of absence.

    Your Profile

    • A university degree in Medicine, Pharmacy, or Life Sciences.
    • Several years of experience and in-depth knowledge of pharmacovigilance.
    • Expertise in global and local pharmacovigilance legislative and non-legislative guidelines.
    • Detailed knowledge of global and local pharmacovigilance SOPs.
    • Experience in performing all key tasks within the pharmacovigilance department.
    • Familiarity with industry principles of pharmacovigilance.
    • Strong organizational and multitasking skills to handle multiple projects.
    • Ability to quickly adapt to new challenges and solve complex problems.
    • Autonomous, focused, and dedicated to delivering high-quality results.
    • Strong teamwork skills and a sense of responsibility.
    • Very good command of English.

    This is a remote position for candidates based in Tunisia with proven senior-level experience in pharmacovigilance.

    Application Instructions

    If you’re interested in this exciting opportunity with Pharmalex, please submit your application, including your earliest possible start date, visa requirements, and salary expectations. Feel free to contact us for further details.

    Agencies may only apply with prior agreement for specific job opportunities.

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    Bucharest :

    Bucharest |

    Makkah :

    Khulais | Rabigh | Jeddah | Riyadh | King Abdullah Economic City | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |