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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. 19, 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: Freelance Local Contact Person - Pharmacovigilance & Regulatory Affairs

Company Description: PrimeVigilance, part of the Ergomed Group, is a specialized pharmacovigilance service provider founded in 2008. We are proud of our organic growth, with a global presence across Europe, North America, and Asia. Our team delivers expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, serving pharmaceutical and biotechnology companies worldwide. We have built lasting relationships with our clients and are leaders in pharmacovigilance, covering all therapeutic areas, including medical devices.

Job Description: We are excited to offer a unique opportunity for a freelancer or consultant to join our team as a Local Contact Person for Pharmacovigilance and Regulatory Affairs (0.5 FTE). This position allows you to strengthen your expertise in pharmacovigilance and regulatory affairs while working within an international team.

Main Responsibilities:

  • Serve as the primary contact for local regulatory authorities and as the 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 ADRs or ICSRs (FUs, translations).
  • Manage and oversee risk minimization measures related to urgent safety restrictions and emerging safety issues.
  • Review and provide linguistic input on local Product Information and mock-ups.
  • Conduct local non-indexed literature screening and monitor regulatory authority websites for potential ADRs and safety information.
  • Support audits and inspections.
  • Handle local quality assurance tasks, such as suspected falsified products, quality alerts from health authorities, and other local market requirements.

Qualifications:

  • Bachelor's Degree in Life Sciences, Chemistry, Nursing, or an equivalent field.
  • Proven experience in the pharmaceutical or CRO industry or regulatory bodies.
  • Must have experience in LCPPV/LCPRA roles.
  • PV training or working experience and other relevant qualifications.
  • Expert knowledge of ICH GVP and local legislation/requirements in relevant territories.
  • Proficiency in English and the local language (both written and verbal).
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Must be set up to work as a freelancer/consultant.

Why PrimeVigilance? PrimeVigilance values diversity, equity, and inclusion, fostering a work environment where people from all backgrounds, genders, and ages can thrive. Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—are central to everything we do. If these values resonate with you, PrimeVigilance could be the perfect fit for you.

We look forward to receiving your application and potentially welcoming you to our team!