Regulatory, Pharmacovigilance and Medical Information Manager

Glenmark Pharmaceuticals; Turbigo; In loco; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Glenmark Pharmaceuticals cerca un Manager per Regulatory, Pharmacovigilance e Medical Information. Il ruolo comprende la garanzia di conformità regolatoria per i medicinali e la creazione di strategie di invio a supporto dei lanci di prodotto. Si richiede un'esperienza consolidata nel settore e competenze bilinguistiche, oltre alla capacità di gestire progetti in modo efficace.

Competenze

• 5-7 anni di esperienza in Regulatory, Pharmacovigilance e Medical Information nel settore farmaceutico.
• Preparazione a gestire informazioni mediche.
• Esperienza in ambienti generici e interazione con fornitori di servizi.

Mansioni

• Assicurare la conformità regolatoria per i medicinali di Glenmark.
• Gestire interazioni con le autorità regolatorie italiane.
• Fornire servizi di informazioni mediche per l'Italia.

Conoscenze

Conoscenza delle normative farmaceutiche italiane ed europee

Bilingue Italiano e Inglese

Competenze di project management

Competenze interpersonali

Capacità di problem solving

Formazione

Laurea in scienze della vita / medicina o qualifica equivalente

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.

Pharmacovigilance Manager • Lombardy, Milan, Italia