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Senior Pv Physician I

2+ years
Not Disclosed
10 April 24, 2025
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

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Job Title: Senior PV Physician I
Location: Remote
Employment Type: Full-time
Department: PV Medical Group


About the Company:

PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider, established in 2008. The company has achieved continuous global organic growth with teams across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners with excellent service, maintaining long-lasting relationships and becoming a global leader in the industry. The company covers all therapy areas, including medical devices.

PrimeVigilance invests in its staff through training and development, emphasizing employee well-being, mental health, and work-life balance to foster an environment that drives high-quality client service.


Job Responsibilities:

  • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment, including coding, seriousness assessment, listedness/expectedness, Company causality, and writing follow-up questions or Company comments

  • Act as a Qualified Person for Pharmacovigilance (QPPV) or support the QPPV in evaluating safety issues as required by the company or client

  • Review literature screening search strategies and assess articles for ICSRs/SAEs or other safety-related findings

  • Contribute to the preparation of Risk Management Plans and support responses to regulatory authority requests

  • Review and provide input for Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Annual Safety Reports

  • Lead a specific pharmacovigilance area requiring medical input, such as the preparation of reference safety information (e.g., Company Core Data Sheet)

  • Participate in signal detection activities, reviewing signal detection reports and providing consultations on benefit/risk assessment and risk minimization

  • Mentor and train junior PV Physicians


Required Qualifications:

  • Medically qualified physician

  • Previous experience in pharmacovigilance

  • Ability to review different aggregate report types, including PBRERs and DSURs

  • Expertise in signal detection activities is essential

  • Excellent interpersonal, communication, and presentation skills

  • Strong organizational, planning, and multitasking abilities

  • Ability to work effectively cross-culturally and cross-functionally, valuing teamwork

  • Advanced proficiency in English (both spoken and written)

  • Advanced literacy in MS Office


What We Offer:

  • Internal training and career development opportunities

  • Strong focus on personal and professional growth

  • A friendly, supportive working environment

  • The opportunity to collaborate with colleagues worldwide, with English as the company language

  • A company culture driven by core values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships