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Pv Officer

0-2 years
Not Disclosed
10 Dec. 31, 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

PV Officer
Location: Remote
Department: ICSR Management
Company: PrimeVigilance (part of Ergomed Group)


Company Description

PrimeVigilance, a mid-size pharmacovigilance service provider, has been delivering excellent services since 2008. As part of Ergomed Group, we have expanded organically across Europe, North America, and Asia, providing comprehensive support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Our success comes from fostering long-lasting relationships with pharmaceutical and biotechnology partners, becoming one of the global leaders in our field. We pride ourselves on investing in staff development and promoting a healthy work-life balance, ensuring a supportive environment that drives high-quality service and employee satisfaction.

Join us and make a positive impact on patients' lives!


Job Description

As a PV Officer at PrimeVigilance, you will take ownership of a range of case processing services with full accountability. You will work with teams of varying sizes, from small clinical trials to large post-marketing teams. We're seeking proactive, capable, and motivated individuals who excel at meeting and exceeding set targets.

Key Responsibilities:

  • Process Individual Case Safety Reports (ICSRs) from all sources (post-marketing, clinical trials, device, and combination products) in compliance with regulations, PrimeVigilance procedures, and client requirements.
  • Independently manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including submissions, unblinding, and clinical trial reconciliations.
  • Prepare database outputs for periodic reports (PBRER, DSUR, PADER, etc.).
  • Mentor and train new or junior employees within the department, optimizing and developing procedures.

Qualifications:

  • Life science or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science) with demonstrated experience in pharmacovigilance case processing.
  • Proven experience in case processing.
  • Strong time management, issue management, delegation, and multitasking skills, with a keen attention to detail.
  • Excellent interpersonal and communication skills.
  • Advanced English proficiency (at least C1), both written and verbal.

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion in an equal opportunities workplace, where people from all cultural backgrounds, genders, and ages can thrive. Our success depends on our people, and we embrace a human-first approach to foster teamwork and continued growth.

What we offer:

  • Internal training and career development opportunities.
  • Strong focus on personal and professional growth.
  • A supportive, friendly working environment.
  • Opportunity to collaborate with global colleagues in English.

Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—are at the heart of everything we do. If these resonate with you, PrimeVigilance could be the ideal place for your career.