Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.
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We are looking for a Local Regulatory Affairs & Pharmacovigilance Specialist in Spain to join our team on a freelance basis for a long-term partnership. This is a fully remote position; however, residency in Spain and fluency in the Spanish language are required to fulfill the responsibilities.
Main Responsibilities:
Regulatory Affairs:
* Act as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups.
* Serve as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements.
* Support the preparation and submission of regulatory applications, including new marketing authorisation (MA) applications, variations, renewals, MA transfers, and related correspondence. Submit national declarations and notifications as required.
* Compile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio.
* Translate and revise product information (e.G., Summary of Product Characteristics, Package Leaflet).
* Validate artworks to ensure compliance with the marketing authorisation and local legislation.
* Review promotional materials for regulatory compliance.
* Advice on launch requirements.
* Manage AEMPS portal.
* Support with labeling exemptions and consultations regarding orphan medicines supply.
* Work within clients' systems.
Pharmacovigilance:
* Act as the Local Person for Pharmacovigilance (LPPV) nominated for National Competent Authority on behalf of Insuvia Clients.
* Serve as the primary contact and subject matter expert for pharmacovigilance advising internal teams and external clients on local regulatory requirements.
* Conduct local literature monitoring for pharmacovigilance purposes by reviewing relevant publications in approved sources
* Monitor local PV legislation and maintain knowledge of local and European regulatory requirements for pharmacovigilance.
* Maintain audit readiness and represent MAH's under responsibility during inspections/audits
* Collect ICSRs and other safety data, including proper local management of it and timely delivery to global PV department.
* Ensure proper local PV system functioning, including but not limited to adaptation and implementation of additional risk minimisation measures (aRRMs), preparation of PV compliance reports, handling other PV related requests
Requirements:
* University degree in medicine, pharmacy, life sciences, or a related field.
* Experience in pharmacovigilance and regulatory affairs (minimum 2 years)
* Fluent in Spanish and English, both written and spoken.
* Strong knowledge of local regulations and requirements.
* Experience serving as a local PV contact (LPPV or deputy) in Spain.
* Attention to detail
* Focused on quality and productivity
* Customer-oriented
Why join us
* Engaging, dynamic and diverse work in a young and rapidly growing company.
* International and multicultural environment.
* A workplace where your input matters and has an impact. xhfqzwm
* Broad opportunities for self-expression and professional growth.
* Remote work