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Pv Physician Ii - Endocrincology Experience

2+ years
Not Disclosed
10 Nov. 25, 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

Company Description:
PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider founded in 2008. With a global presence across Europe, North America, and Asia, we offer services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Our commitment to excellence has earned us a reputation as a leader in the field, supporting pharmaceutical and biotechnology partners across all therapy areas, including medical devices. We invest in our staff by offering robust training and development, promoting well-being, and maintaining a healthy work-life balance.

Job Description:
We are seeking a Senior Pharmacovigilance (PV) Physician II to join our team. The role involves the medical review of Individual Case Safety Reports (ICSRs), signal detection, aggregate report writing, and mentoring junior PV physicians. The Senior PV Physician II will support the Qualified Person for Pharmacovigilance (QPPV) in addressing medical aspects and safety issues for clients, ensuring adherence to pharmacovigilance standards.

Key Responsibilities:

  • Review and approve ICSRs, Serious Adverse Event (SAE) reports, and ensure proper medical/causality assessment.
  • Complete and track adverse event data, including follow-up questions and analysis of similar events.
  • Act as or support the QPPV in medical evaluations of safety issues.
  • Review literature screening search strategies and analyze safety-related findings from articles.
  • Contribute to the preparation of Risk Management Plans and regulatory responses.
  • Lead or participate in the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
  • Oversee signal detection activities, evaluate benefit-risk assessments, and propose action plans for identified signals.
  • Provide medical input for reference safety information and participate in safety review committees.
  • Train, mentor, and manage junior PV physicians, ensuring continuous procedural development.
  • Support the preparation of pharmacovigilance procedures and quality assurance metrics.

Qualifications:

  • Medical degree with experience in Pharmacovigilance and clinical settings.
  • Endocrinology experience is required.
  • Strong interpersonal, organizational, and communication skills.
  • Ability to work cross-functionally and effectively with diverse teams.
  • Excellent presentation and communication abilities.

Additional Information:
We prioritize diversity, equity, and inclusion, fostering a human-centric environment where people of all backgrounds can thrive. PrimeVigilance offers a supportive work environment, career development opportunities, and the chance to collaborate with colleagues worldwide. If you align with our values of quality, integrity, and collaboration, we invite you to join us in making a positive impact on patients' lives.

Core Values:

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

We look forward to welcoming your application and joining our exciting journey to improve patient care.