Pharmacovigilance Physician

3+ years

Not Disclosed

Remote

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: MD 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

Location: PrimeVigilance (Global: North America, Europe, Asia)

About PrimeVigilance

PrimeVigilance is a leading provider of pharmacovigilance and drug safety services, supporting the pharmaceutical industry in ensuring the safety and efficacy of medicinal products throughout their lifecycle. We are dedicated to improving patient safety by providing regulatory expertise, comprehensive pharmacovigilance services, and advanced technologies. Our global teams operate in North America, Europe, and Asia.

Key Accountabilities

As a Pharmacovigilance Physician, your primary responsibilities will include:

Safety Report Review:
- Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment.
- Perform comprehensive assessments, including coding, seriousness evaluation, expectedness, and causality analysis.
Medical Writing and Documentation:
- Write company comments, formulate follow-up questions, and analyze similar events to provide complete documentation.
- Ensure the completion of all required supporting documentation such as trackers and records for further review.
Collaboration:
- Support the Qualified Person for Pharmacovigilance (QPPV) (if not medically qualified) in the medical understanding and evaluation of any safety issues that arise.
- Contribute to the creation and review of periodic reports, ensuring that they are comprehensive and compliant with industry standards.
Literature Screening and Safety Analysis:
- Review literature screening strategies and analyze articles to identify if they contain ICSRs/SAEs related to the relevant medicinal product or any other safety findings.

Qualifications

Medical Degree (MD):
- An MD qualification is required for this role, enabling you to review and assess safety reports effectively.
Key Skills:
- Planning and Organizing: Ability to plan, prioritize, and execute multiple tasks effectively in a fast-paced environment.
- Cross-Cultural and Cross-Functional Collaboration: Ability to work effectively across different teams and cultures, fostering strong teamwork.
- Communication Skills: Strong communication and presentation skills, ensuring clear and precise reporting.
Language Skills:
- Advanced English proficiency (both verbal and written) at least at a B2 level.
Technical Proficiency:
- Advanced knowledge of MS Office (Word, Excel, PowerPoint) is essential for preparing reports and analyzing data.

Additional Information

This position offers Medical Doctors an excellent opportunity to begin or further develop a career in pharmacovigilance and drug safety. As a Pharmacovigilance Physician with PrimeVigilance, you will be integral to ensuring the safety of medicinal products in the marketplace by providing crucial medical assessments and supporting critical drug safety activities.

PrimeVigilance offers a supportive, global environment where you can grow professionally, work with experienced teams, and contribute to improving patient safety across the world.

PrimeVigilance is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Pharmacovigilance Physician

Job Description

Job Title: Pharmacovigilance Physician

About PrimeVigilance

Key Accountabilities

Qualifications

Additional Information

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