Regulatory, Pharmacovigilance and Medical Information Manager

Glenmark Pharmaceuticals; Monza; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global pharmaceutical company is seeking a Regulatory, Pharmacovigilance and Medical Information Manager. In this role, you will ensure regulatory compliance and manage effective interactions with authorities, while delivering timely medical information services. The ideal candidate will have a strong background in regulatory affairs and pharmacovigilance, along with significant experience in the pharmaceutical industry.

Competenze

• 5-7 years in Regulatory, Pharmacovigilance, and Medical Information in Pharma.
• Deep knowledge of Italian and EU Pharmaceutical Regulations.
• Experience in generic environment.

Mansioni

• Ensure regulatory compliance for all medicinal products.
• Manage interactions with Italian regulatory authorities.
• Deliver Medical Information services for Italy.

Conoscenze

Project Management

Negotiation

Problem Solving

Interpersonal Skills

Multitasking

Formazione

Life Science / Medical Degree

Descrizione del lavoro

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.

The role ensures regulatory compliance for all Glenmark medicinal. 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

DESIRED EXPERIENCE AND KNOWLEDGE

Educational Qualifications

Life science / medical degree or equivalent qualification.

Experience

• 5-7 years in Regulatory, Pharmacovigilance and Medical Information role in Pharma Industry
• Deep knowledge of Italian and EU Pharmaceutical Regulations
• Experience in generic environment
• Demonstrable 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.
• Demonstrable oversight and interfacing with service providers.
• Awareness of Pharmacovigilance and Quality Assurance including interaction and support of such functions.
• Demonstrable optimization of MI services to support other functions including but not limited to commercial operations (Sales and Marketing), Regulatory, Pharmacovigilance and Legal.

Knowledge and Skills ( Functional / Technical )

• Bilingual including Italian and English for support medical information operational languages.
• 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 team.
• Excellent interpersonal, negotiation, decision making and problem solving skills.
• Ability to establish and maintain open relationships within the organization and with external stakeholder.
• Business acumen.

Behavioural Attributes

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