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Pv Officer

2+ years
Not Disclosed
10 Oct. 17, 2024
Job Description
Job Type: Full Time Remote 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

PV Officer

Employees can work remotely
Full-time
Department: ICSR Management

Company Description

We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We take pride in our consistent global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance delivers top-tier support to pharmaceutical and biotechnology partners, fostering enduring relationships and establishing ourselves as leaders in the field. We cover all therapy areas, including medical devices.

We are committed to investing in our staff through robust training and development programs. We prioritize employee experience, well-being, and mental health, recognizing that a healthy work-life balance is essential for satisfaction and high-quality client service.

Job Description

As a PV Officer, you will be an independent case processing team member responsible for managing a variety of case processing services with full accountability.

Joining PrimeVigilance means working with teams of varying sizes, from small clinical trials to large post-marketing efforts. We seek proactive, capable, and motivated individuals who aim to exceed targets.

The PV Officer should have a life sciences or biomedical background, or possess a related healthcare degree (chemistry, biology, biotechnology, veterinary science, etc.), along with demonstrated experience in case processing. You will work as part of a project team, supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to achieve and maintain high performance levels within three months of joining an ICSR team after onboarding.

Responsibilities:

  • Process Individual Case Safety Reports (ICSRs) from all sources (post-marketing and clinical trials, including devices and combination products) in compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements and timelines. You will effectively cover all steps of the workflow cycle, except Medical Review.
  • Independently manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) (submissions, unblinding, clinical trial reconciliations).
  • Prepare database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
  • Mentor and train new and junior employees, optimizing and developing procedures.

Qualifications

Requirements:

  • Life sciences or biomedical background with a healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in pharmacovigilance case processing.
  • Proven case processing experience; ARGUS experience is preferred.
  • Strong time management, organizational, and multitasking skills, with excellent attention to detail.
  • Strong interpersonal and communication skills.
  • Advanced English skills (both verbal and written), at least C1 level.

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by fostering an equal-opportunity workplace where individuals of all cultural backgrounds, genders, and ages can contribute and grow.

To succeed, we must collaborate with a human-first approach. Our people are our greatest strength, driving our success in improving lives.

Our Offer:

  • Training and career development opportunities.
  • Strong emphasis on personal and professional growth.
  • A friendly, supportive working environment.
  • Opportunity to collaborate with colleagues worldwide, with English as the company language.

If our core values resonate with you, PrimeVigilance could be the right fit!

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

We look forward to welcoming your application!