Senior Pv Physician I

Primevigilance

5+ years

Not Disclosed

Remote, USA

10 Nov. 19, 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

Job Title: Pharmacovigilance Physician (Qualified Person for Pharmacovigilance)

Company Description: PrimeVigilance, part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider, established in 2008. We have grown organically year after year, with a global presence across Europe, North America, and Asia. Our team provides services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports pharmaceutical and biotechnology companies of all sizes, fostering long-lasting relationships and solidifying its position as a global leader in its field. We cover all therapy areas, including medical devices.

At PrimeVigilance, we invest in the development of our staff, emphasizing employee well-being, mental health, and work-life balance. We believe that a healthy, balanced work environment enhances both employee satisfaction and the high-quality client service we provide.

Job Description: PrimeVigilance is seeking a qualified Pharmacovigilance Physician (Qualified Person for Pharmacovigilance) to join our team. The role involves reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for clinical trials, including tasks like coding, seriousness assessment, and causality evaluations.

Key Responsibilities:

Review and approve ICSR and SAE reports, ensuring proper coding, seriousness assessment, company causality, listedness/expectedness, and follow-up questions.
Act as a Qualified Person for Pharmacovigilance or support the Qualified Person (if not medically qualified) in evaluating safety issues.
Contribute to the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening strategies.
Review articles to identify ICSRs/SAEs related to relevant medicinal products and safety-related findings.
Assist in Risk Management Plans and regulatory authority requests.
Engage in signal detection activities, including reviewing line listings, writing signal detection reports, and providing client consultation on benefit/risk assessments and risk minimization.
Evaluate and categorize potential safety signals and propose appropriate actions.
Support the preparation and review of benefit-risk reports.

Qualifications:

Medically qualified physician.
Previous experience in pharmacovigilance.
Strong ability to review aggregate reports, including PBRERs and DSURs.
Expertise in signal detection activities.
Excellent interpersonal, organizational, and prioritization skills.
Ability to work effectively across cultures and teams.
Strong communication and presentation skills.
Advanced proficiency in English (spoken and written).
Proficiency in MS Office.

Why Join PrimeVigilance? At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating a workplace where people from all cultural backgrounds, genders, and ages can thrive. We believe that our people are our greatest strength, and we work together with a human-first approach to improve the lives of those around us.

We offer:

Training and career development opportunities.
A strong focus on personal and professional growth.
A supportive, friendly work environment.
The chance to collaborate with colleagues globally, with English as the company language.

If our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—resonate with you, PrimeVigilance is the right place for you.

Join us on our exciting journey to make a positive impact on patient lives. We look forward to receiving your application!

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Senior Pv Physician I

Job Description

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