Local Qualified Person For Pharmacovigilance (Qppv) Freelancer

5 years

Not Disclosed

Netherlands Remote

10 Feb. 18, 2025

Job Description

Job Type: 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: Local Qualified Person for Pharmacovigilance (QPPV) Freelancer
Location: Netherlands (Remote)
Additional Locations: Estonia, Slovakia, Athens (Greece), Berlin (Germany), Bern (Switzerland), Brisbane (Australia), Budapest (Hungary), Lisbon (Portugal), Milano (Italy), Paris (France), Prague (Czechia), Ra'anana (Israel), Riga (Latvia), Sofia (Bulgaria), Turkey (Türkiye), Vilnius (Lithuania), Warsaw (Poland), Wavre (Belgium), Zagreb (Croatia)
Job ID: R0000020682
Category: Clinical Logistics

Company Overview:

Our company is a global leader in providing end-to-end solutions in the life sciences industry. We support pharmaceutical, biotechnology, and medical device companies in the development, manufacture, and commercialization of products. As part of our growing global team, we are seeking a Local Qualified Person for Pharmacovigilance (QPPV) to join us on a freelance basis.

Job Overview:

The Local Qualified Person for Pharmacovigilance (QPPV) will be responsible for ensuring compliance with pharmacovigilance (PV) regulations within the local region and monitoring the safety of medicinal products. This role will be critical in maintaining the integrity of the safety profile of marketed and investigational medicinal products and ensuring the quality of pharmacovigilance data in compliance with global regulatory requirements.

Key Responsibilities:

Pharmacovigilance Management:

Ensure that the pharmacovigilance system meets all regulatory and legal requirements for the local market.
Oversee the reporting of adverse events (AEs) and serious adverse events (SAEs) in compliance with local regulations.
Ensure timely submission of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other required safety documents to the relevant authorities.
Monitor local pharmacovigilance activities, including data collection, safety assessments, and reporting.
Act as the primary point of contact for the regulatory authority in the event of safety concerns.

Regulatory Compliance & Reporting:

Ensure adherence to the pharmacovigilance guidelines and regulations specific to each market.
Provide expertise in pharmacovigilance to local and global teams, ensuring compliance across all regions.
Monitor and ensure compliance with the safety data reporting timelines set by regulatory agencies.

Risk Management:

Participate in the development and maintenance of Risk Management Plans (RMPs) and mitigation strategies.
Conduct risk assessments and ensure all necessary pharmacovigilance activities are properly documented and tracked.
Proactively identify, assess, and mitigate safety risks for medicinal products.

Collaboration & Communication:

Collaborate closely with cross-functional teams (clinical, regulatory, medical affairs) to ensure effective safety management.
Maintain effective communication with external stakeholders, including regulatory agencies and health authorities.

Qualifications:

Education & Experience:

Medical Doctor (MD), Pharmacist, or equivalent qualification in a relevant scientific discipline.
A minimum of 5 years of experience in pharmacovigilance, with experience as a Qualified Person for Pharmacovigilance (QPPV) or similar role.
Strong knowledge of local and global pharmacovigilance regulations and guidelines (e.g., ICH E2E, EU Directive 2001/83/EC, FDA regulations).
Experience with safety databases, signal detection, and risk management is preferred.

Skills & Abilities:

Exceptional attention to detail and strong organizational skills.
Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
Strong verbal and written communication skills in English; proficiency in additional languages is a plus.
Ability to collaborate with global teams and influence at all levels of an organization.

Additional Information:

This position is offered on a freelance/contract basis.
The role is remote with the flexibility to work from various locations in Europe, Australia, and Israel.

Join our team and contribute to the continued development and safety of life-saving treatments globally!

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Local Qualified Person For Pharmacovigilance (Qppv) Freelancer

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