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Freelance / Consultant 0.5 Fte Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra)

2+ years
Not Disclosed
10 Nov. 25, 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

Company Description:
We are PrimeVigilance, part of the Ergomed Group, a specialized mid-sized pharmacovigilance service provider established in 2008. We are proud of our consistent global organic growth, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in the industry. We cover a wide range of therapy areas, including medical devices.

Job Description:
An exciting opportunity has arisen for a freelancer/consultant to join our team as the Local Contact Person for Pharmacovigilance and Regulatory Affairs at a 0.5 FTE capacity. This role offers the chance to work in an international team, strengthening your expertise in the broad field of Pharmacovigilance (PV) and Regulatory Affairs.

Main Responsibilities:

  • Serve as the primary contact for local regulatory authorities and act as a Pharmacovigilance expert according to local requirements.
  • Ensure prompt and effective communication with local regulatory authorities.
  • Provide local regulatory intelligence screening and expert advice.
  • Collect and report locally suspected Adverse Drug Reactions (ADRs) or Individual Case Safety Reports (ICSRs), including follow-ups and translations.
  • Oversee local risk minimization measures for urgent safety restrictions and emerging safety issues.
  • Review and provide linguistic input on local Product Information and Mock-ups.
  • Perform local non-indexed literature screening and monitor Regulatory Authority websites for potential ADRs and safety information.
  • Support audits and inspections.
  • Manage local QA tasks such as suspected falsified products, quality alerts from Health Authorities (HA), and other quality-related local requirements.

Qualifications:

  • Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent experience.
  • Demonstrated experience within the pharmaceutical, CRO industry, or regulatory bodies.
  • Experience in LCPPV (Local Contact Person for Pharmacovigilance) and LCPRA (Local Contact Person for Regulatory Affairs) roles.
  • PV training and/or work experience, and any relevant educational or professional background required locally.
  • Expert knowledge of ICH GVP and the most relevant legislation/local requirements for your specific territories.
  • Proficiency in English, both written and verbal, and in the local language.
  • Proficiency in all MS-Office applications, including Microsoft Word, Excel, and PowerPoint.
  • Must be set up to work as a freelancer/consultant.

Additional Information:
We prioritize diversity, equity, and inclusion by fostering an equal opportunities workplace where individuals of all backgrounds, genders, and ages can contribute and grow.

Our company believes in a human-first approach, as we recognize that our people are our greatest strength. This focus leads to the continued success of our mission to improve the lives of others.

Our core values:

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

If our values resonate with you, PrimeVigilance could be the ideal place for you to thrive.

We look forward to welcoming your application!