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Pharmacovigilance Associate (Psmf) (Homebased)

0-2 years
Not Disclosed
10 Oct. 18, 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

Job Title: Pharmacovigilance Associate (PSMF) - Remote

Location: Home-based
Employment Type: Full-time
Department: PSMF Department

Company Description

PrimeVigilance, part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider established in 2008. With a focus on global organic growth, our team spans Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

We pride ourselves on providing top-notch support to our pharmaceutical and biotechnology partners, fostering long-lasting relationships, and becoming a global leader in our field. Our expertise covers all therapy areas, including medical devices.

At PrimeVigilance, we invest in our staff through excellent training and development opportunities. We prioritize employee experience, well-being, and mental health, recognizing that a healthy work-life balance is essential for job satisfaction and delivering high-quality client service.

Join us in our exciting journey to positively impact patients' lives!

Job Description

As a Pharmacovigilance Associate, you will be primarily responsible for creating, maintaining, and reviewing client Pharmacovigilance System Master Files (PSMF) in accordance with global regulations, legislation, and both PrimeVigilance and client requirements. Your tasks will include:

  • Authoring and revising PSMF documents
  • Conducting quality checks and reviews
  • Tracking changes and updates
  • Attending regular PSMF meetings with internal teams and clients
  • Completing tasks assigned by the Line Manager
  • Providing training in the PSMF area
  • Revising and updating related quality documents

Qualifications

  • Preferred degree in life sciences (pharmacy, nursing, or related healthcare field)
  • Some experience or knowledge in Pharmacovigilance
  • Strong organizational skills, attention to detail, and multitasking ability
  • Management skills, including time and issue management
  • Excellent communication skills

Additional Information

Why PrimeVigilance?

We are committed to diversity, equity, and inclusion, creating an equal-opportunity workplace where individuals from all backgrounds can thrive. Our human-centric approach emphasizes collaboration, as our people are our greatest strength.

What We Offer:

  • Training and career development opportunities
  • Strong focus on personal and professional growth
  • A friendly, supportive working environment
  • Collaboration with colleagues worldwide, with English as the primary language

If our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—resonate with you, PrimeVigilance could be your ideal workplace!

Join us in our mission to make a positive impact on patients' lives. We look forward to welcoming your application!