REGULATORY, PHARMACOVIGILANCE AND MEDICAL INFORMATION MANAGER

Pharma Point Srl; Monza; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

Un'azienda farmaceutica globale è in cerca di un Manager di Regolamentazione, Farmacovigilanza e Informazioni Mediche per garantire la conformità e gestire interazioni con le autorità. Richiesta esperienza di 5-7 anni nel settore con forte conoscenza delle normative italiane ed europee.

Competenze

• 5-7 anni di esperienza in ruoli di regolamentazione e farmacovigilanza nel settore farmaceutico.
• Conoscenza approfondita delle normative farmaceutiche italiane ed EU.
• Esperienza pregressa in un ambiente generico.

Mansioni

• Assicurare la conformità regolatoria per tutti i prodotti medicinali.
• Gestire le interazioni con le autorità regolatorie italiane per le attività di lancio.
• Fornire servizi di informazione medica per l'Italia.

Conoscenze

Bilinguismo in Italiano e Inglese

Capacità di gestione progetti

Competenze negoziali

Competenze di problem-solving

Formazione

Laurea in scienze della vita / medicina o qualifica equivalente

Descrizione del lavoro

REGULATORY, PHARMACOVIGILANCE AND MEDICAL INFORMATION MANAGER

On behalf of Glenmark Pharmaceuticals Ltd, an innovation-driven global pharmaceutical company with a presence across Specialty, Generics, and OTC businesses, Pharma Point is seeking a Regulatory, Pharmacovigilance, and Medical Information Manager .

Role Overview / Purpose

This role ensures regulatory compliance for all Glenmark medicinal products. It involves defining and implementing submission strategies in collaboration with EU regulatory teams and local business units. The role also manages interactions with Italian regulatory authorities to support product launches and lifecycle management.

In pharmacovigilance, the role ensures timely and accurate communication of safety issues to enable appropriate actions. Additionally, it provides Medical Information services for Italy, supporting European and Global MI teams by delivering accurate, timely, and compliant information to promote the appropriate use of Glenmark products.

Desired Experience and Knowledge

Educational Qualifications

Life science / medical degree or equivalent qualification.

Experience

• 5-7 years in Regulatory, Pharmacovigilance, and Medical Information roles within the Pharma industry.
• Deep knowledge of Italian and EU Pharmaceutical Regulations.
• Experience in a generic environment.
• Previous medical information experience of at least 18 months or related experience in biotechnology, pharmaceutical, or CRO environments.
• Familiarity with Medical Information practices, CAPA management, audits, and inspections.
• Oversight and interfacing with service providers.
• Awareness of Pharmacovigilance and Quality Assurance functions.
• Experience in optimizing MI services to support functions such as commercial operations, Regulatory, Pharmacovigilance, and Legal.

Knowledge and Skills (Functional / Technical)

• Bilingual proficiency in Italian and English.
• Strong prioritization and multi-tasking abilities.
• Excellent project management skills, with the ability to coordinate internal and external resources in cross-functional teams.
• Strong interpersonal, negotiation, decision-making, and problem-solving skills.
• Ability to establish and maintain relationships within the organization and with external stakeholders.
• Business acumen.

Behavioral Attributes

• Ability to work independently and collaboratively within cross-functional teams.
• Supportive of company initiatives for holistic development.

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