REGULATORY, PHARMACOVIGILANCE AND MEDICAL INFORMATION MANAGER

Experteer Italy; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Regulatory, Pharmacovigilance and Medical Information Manager in Milan. This crucial role involves ensuring regulatory compliance for medicinal products, managing pharmacovigilance activities, and delivering medical information services, requiring extensive experience in the pharmaceutical industry. Ideal candidates will possess a life science degree and bilingual proficiency in Italian and English.

Competenze

• 5-7 years experience in Regulatory, Pharmacovigilance and Medical Information roles.
• Deep knowledge of Italian and EU Pharmaceutical Regulations.
• Previous medical information experience over at least 18 months in a relevant setting.

Mansioni

• Ensure regulatory compliance for all Glenmark medicinal products.
• Manage timely communication of safety issues in pharmacovigilance.
• Deliver Medical Information services for Italy and support product launches.

Conoscenze

Bilingual in Italian and English

Project Management

Interpersonal Skills

Negotiation Skills

Problem-Solving Skills

Formazione

Life science/medical degree

Descrizione del lavoro

Business unit

Farmacovigilanza; Regolatorio

Sedi

Italia/Lombardia/Milano

On Behalf of Glenmark Pharmaceuticals Ltd, an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses, Pharma Point is looking for a

Regulatory, Pharmacovigilance and Medical Information Manager.

ROLE OVERVIEW/ PURPOSE

The role ensures regulatory compliance for all Glenmark medicinal products. The position defines and implements submission strategies in collaboration with EU regulatory teams and the local business. It also manages effective interactions with Italian regulatory authorities to support product launches and lifecycle maintenance.

In pharmacovigilance, the role ensures timely and accurate communication of safety issues, enabling Glenmark to take appropriate actions.

Additionally, the position delivers Medical Information services for Italy, as part of the broader European and Global MI teams. The function focuses on providing accurate, timely, and compliant information to support 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 in the Pharma Industry
• Deep knowledge of Italian and EU Pharmaceutical Regulations
• Experience in a generic environment
• Previous medical information experience preferably acquired over at least 18 months or related experience in a biotechnology or pharmaceutical company or CRO environment.
• Familiarity with Medical Information practices, CAPA Management, audit and inspection processes.
• Oversight and interfacing with service providers.
• Awareness of Pharmacovigilance and Quality Assurance including interaction and support of such functions.
• Optimization of MI services to support functions including commercial operations (Sales and Marketing), Regulatory, Pharmacovigilance, and Legal.

Knowledge and Skills (Functional / Technical)

• Bilingual in Italian and English to support medical information operations.
• Ability to prioritize and multi-task successfully.
• Excellent project management skills with the ability to align internal and external resources and work in cross-functional teams.
• Excellent interpersonal, negotiation, decision-making, and problem-solving skills.
• Ability to establish and maintain open relationships within the organization and with external stakeholders.
• Business acumen.

Behavioural Attributes

• Ability to work independently and as part of cross-functional teams.
• Support company initiatives for holistic development of the company.