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

2+ years

Not Disclosed

Remote - Europe

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 for Pharmacovigilance and Regulatory Affairs (0.5 FTE)

Company Description: PrimeVigilance, part of the Ergomed Group, is a specialized mid-sized pharmacovigilance service provider founded in 2008. We are proud of our continuous global organic growth, with teams across Europe, North America, and Asia. We offer expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, supporting pharmaceutical and biotechnology companies of all sizes. We provide global leadership in the field and cover a wide range of therapy areas, including medical devices.

Job Description: We are seeking a freelancer/consultant to join us as the Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE. This position offers an exciting opportunity to work within an international team and expand your expertise in the broad and diverse fields of Pharmacovigilance (PV) and Regulatory Affairs.

Main Responsibilities:

Act as the primary contact person for local regulatory authorities and provide pharmacovigilance expertise as required.
Maintain prompt and effective communication with local regulatory authorities.
Provide local regulatory intelligence screening and expert advice.
Collect and report locally suspected ADRs or ICSRs (Follow-ups, translations).
Oversee and manage local risk minimization measures related to urgent safety restrictions and emerging safety issues.
Review and provide linguistic input for local Product Information and Mock-ups.
Conduct local non-indexed literature screening and monitor Regulatory Authority websites for ADRs and safety information.
Support audits and inspections.
Handle local Quality Assurance tasks, such as suspected falsified products, quality alerts from Health Authorities (HA), and other market-specific quality requirements.

Qualifications:

Bachelor’s Degree in Life Sciences, Chemistry, Nursing, or equivalent.
Proven experience within the pharmaceutical or CRO industry or regulatory bodies.
Experience in LCPPV / LCPRA roles is required.
PV training and/or working experience, or other educational qualifications as required by the local territory.
Expert knowledge of ICH GVP and relevant local legislation and requirements.
Proficiency in English (written and verbal) and the local language.
Strong skills in Microsoft Word, Excel, and PowerPoint.
Must be set up to work as a freelancer/consultant.

Why PrimeVigilance? At PrimeVigilance, we foster diversity, equity, and inclusion, creating a work environment where people from all backgrounds, genders, and ages can thrive. Our success is driven by our people, and we believe in a human-first approach to improve lives around us.

Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—guide how we work. If these values align with your own, PrimeVigilance could be the perfect company for you.

We look forward to receiving your application!

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

Job Description

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