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    Senior Pv Physician I

    Primevigilance
    2+ years
    Not Disclosed
    Remote
    10 Dec. 31, 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

    Senior PV Physician I
    Location: Remote
    Department: PV Medical Group
    Company: PrimeVigilance (part of Ergomed Group)

    Company Description

    PrimeVigilance, a specialized mid-size pharmacovigilance service provider, has been delivering outstanding services since 2008. As part of Ergomed Group, we have achieved organic global growth year after year with staff across Europe, North America, and Asia. We provide top-tier services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    We are committed to fostering long-lasting relationships with our pharmaceutical and biotechnology partners, making us a global leader in our field. Our culture is built on investing in our staff through excellent training, development, and a focus on employee well-being, mental health, and work-life balance.

    Job Description

    As a Senior PV Physician I at PrimeVigilance, you will:

    • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports in clinical trials for medical/causality assessment. This includes coding, seriousness assessment, company causality, listedness/expectedness, and follow-up questions.
    • Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in evaluating safety issues.
    • Contribute to the review of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening search strategies.
    • Assess articles to determine if they contain ICSRs/SAEs or other safety findings related to medicinal products.
    • Provide input into Risk Management Plans and assist in preparing responses to regulatory authority requests.
    • Participate in signal detection activities, including reviewing line listings, writing signal detection reports, and advising clients on benefit/risk assessment and risk minimization strategies.
    • Categorize possible signals and recommend appropriate courses of action.
    • Support the preparation and review of benefit-risk reports.

    Qualifications

    • Medical qualification as a physician (Required).
    • Previous experience in pharmacovigilance.
    • Expertise in reviewing aggregate report types such as PBRERs and DSURs.
    • Strong background in signal detection activities.
    • Excellent interpersonal, communication, and presentation skills.
    • Ability to plan, organize, prioritize, and execute multiple tasks effectively.
    • Ability to work cross-culturally and cross-functionally, fostering teamwork.
    • Advanced English proficiency (spoken and written).
    • Advanced skills in MS Office.

    Why PrimeVigilance?

    We value diversity, equity, and inclusion, ensuring an equal opportunities workplace where people from all backgrounds, genders, and ages can thrive. Our success depends on our people, and we pride ourselves on fostering a human-first approach to support continued success and improve lives worldwide.

    What we offer:

    • Internal training and career development opportunities.
    • Strong emphasis on personal and professional growth.
    • A friendly, supportive working environment.
    • Opportunity to collaborate with colleagues globally, with English as the company language.

    Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—guide everything we do. If these values resonate with you, PrimeVigilance is the place to grow your career and make a positive impact in patients' lives.

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