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Medical Reviewer Ii

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:
We are PrimeVigilance, a specialized, mid-sized pharmacovigilance service provider and part of the Ergomed Group. Established in 2008, we have achieved consistent global growth, with teams based in Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance is a trusted partner to both small and large pharmaceutical and biotechnology companies, providing first-class support and building long-term relationships. We cover all therapeutic areas, including medical devices.

We are committed to investing in our employees' professional growth by providing a robust training and development platform. We place great importance on employee well-being, mental health, and work-life balance, which in turn fosters a high-quality service environment for our clients.

Join us in our mission to positively impact patient lives globally.

Job Description:
We are looking for a Medical Reviewer II to join our team. This role involves the medical review of Individual Case Safety Reports (ICSRs), literature review, writing signal detection reports, and supporting the preparation of aggregate reports such as DSURs, PSURs, PBRERs, and PADERS.

Key Responsibilities:

For the Client:

  • Review and approve post-marketing ICSRs and SAEs for medical and causality assessment.
  • Act as the Qualified Person for Pharmacovigilance or support the Qualified Person in medical understanding and evaluation of safety issues.
  • Review and provide input in Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature search strategies.
  • Review articles for ICSRs/SAEs or safety-related findings.
  • Contribute to the preparation and input of Risk Management Plans.
  • Support the preparation of responses to regulatory authority requests.
  • Participate in signal detection activities, including line listings review, report writing, and consultation on benefit-risk assessments.
  • Evaluate and categorize signals and propose action plans.
  • Support the preparation and review of benefit-risk reports.

For the Company:

  • Write pharmacovigilance procedures.
  • Mentor less experienced physicians in the team.

Qualifications:

  • Medically qualified physician.
  • Previous experience in pharmacovigilance.
  • Expertise in signal detection activities.
  • Ability to review and interpret aggregate reports (e.g., PBRERs, DSURs).
  • Strong interpersonal and communication skills.
  • Excellent organizational and multitasking abilities.
  • Ability to work cross-culturally and cross-functionally within a team environment.
  • Advanced proficiency in English (spoken and written).
  • Proficient in MS Office.

Additional Information:
At PrimeVigilance, we value diversity, equity, and inclusion, creating a human-centric workplace where individuals of all backgrounds can thrive and contribute.

We offer:

  • Internal training and career development opportunities.
  • Emphasis on personal and professional growth.
  • A friendly, supportive work environment.
  • Opportunities to collaborate with colleagues worldwide, using English as the company language.

Core Values:

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

If our values resonate with you, PrimeVigilance could be the perfect place to further your career. Join us in making a positive impact on patient lives!

We look forward to receiving your application.