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    Senior Pv Physician I

    Primevigilance
    2+ years
    Not Disclosed
    Pune
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Job Title: Senior PV Physician I
    Company: PrimeVigilance (part of Ergomed Group)
    Location: Remote
    Employment Type: Full-time

    Company Overview:

    PrimeVigilance is a global leader in pharmacovigilance services, part of Ergomed Group. Founded in 2008, PrimeVigilance has achieved steady organic growth with a global presence across Europe, North America, and Asia. The company specializes in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance services for pharmaceutical and biotechnology partners. PrimeVigilance serves all therapy areas, including medical devices, and prides itself on maintaining long-lasting relationships with clients. The company invests in employee development, well-being, and work-life balance to deliver top-tier client services.

    Job Description:

    As a Senior PV Physician I, you will play a key role in reviewing and approving Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. You will also contribute to safety evaluations and support the Qualified Person for Pharmacovigilance in understanding and evaluating safety concerns. This includes reviewing periodic safety reports, literature screening, and supporting risk management plans. You will be involved in signal detection activities and assessing benefit-risk reports for medicinal products.

    Key Responsibilities:

    • Review and approve ICSRs and SAE reports for medical/causality assessment, including coding, seriousness, causality, and follow-up questions.
    • Act as a Qualified Person for Pharmacovigilance or support the QPPV in evaluating safety issues.
    • Contribute to the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans.
    • Review literature to identify relevant ICSRs/SAEs and safety-related findings.
    • Participate in signal detection activities, including meetings and preparing signal detection reports.
    • Categorize and evaluate possible safety signals, propose courses of action, and provide consultation to clients on benefit-risk assessments.
    • Support the preparation of benefit-risk reports and regulatory authority responses.

    Qualifications:

    • Medically qualified as a physician.
    • Previous experience in pharmacovigilance.
    • Ability to review aggregate reports such as PBRERs and DSURs.
    • Expertise in signal detection and safety assessments is essential.
    • Strong interpersonal and communication skills.
    • Ability to plan, organize, and prioritize tasks efficiently.
    • Experience working effectively cross-culturally and cross-functionally.
    • Advanced proficiency in English (both spoken and written).
    • Proficient in MS Office tools.

    Why PrimeVigilance?

    PrimeVigilance prioritizes diversity, equity, and inclusion, fostering a workplace where individuals from all cultural backgrounds, genders, and ages can contribute and thrive. The company is committed to a human-first approach, recognizing that employees are its greatest strength, driving success in improving patients' lives.

    Core Values:

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    PrimeVigilance offers excellent training and career development opportunities, a supportive work environment, and the chance to collaborate with colleagues worldwide in an English-speaking environment.

    Join PrimeVigilance to be part of a dynamic team, making a positive impact on patient safety and health.

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    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 :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |