Patient Safety Manager

Overview

Randstad Office Milan is looking for a Patient Safety Manager for our pharmaceutical partner. This role provides crucial support to the Affiliate Head of Patient Safety (AHoPS), working closely with both local and global teams. The Manager is responsible for various aspects of pharmacovigilance (PV) coordination and execution at the affiliate level, potentially acting as the named deputy AHoPS / Local Legal PV Responsible Person, in line with local legal requirements. The position is integral in ensuring strong engagement and integration of Patient Safety within the local business.

Offer

Contract Type: Fixed-term contract for one (1) year.

Working Model: Hybrid work model with 2 days of smart working per week.

Remuneration: Commensurate with experience gained in the pharmaceutical sector and in the Pharmacovigilance Manager role (up to 70K) + voucher meal ticket (10€).

Retribuzione annua: 50000€ - 65000€

Esperienza

da 3 a 5 anni

Qualifications

• Required Competencies / Education and / or Experience
• Confirmed practical experience in pharmacovigilance.
• Comprehensive understanding of drug safety regulations and obligations.
• Ability to work with a high degree of autonomy.
• Proven leadership or influencing skills.
• Excellent communication skills.
• Very good written and spoken English.
• Ability to represent the company externally.

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Responsibilities

• Strategic PV Partner: Brings local insights to safety decision-making, including benefit / risk assessments and risk management development.
• Program Oversight: Partners on local projects (e.g., Patient Support Programs, Market Research) to ensure compliant safety solutions.
• Regulatory Compliance: Acts as the local safety contact point, contributing to PV audits / inspections and ensuring local PV activities comply with standards.
• Expert Knowledge: Maintains expert knowledge of local PV regulations, interpreting their impact and communicating changes to the global team.
• Safety Communication: Submits or delegates submission of relevant safety information to authorities (e.g., PSUR, RMP).
• Quality & Training: Acts as the Patient Safety ambassador, providing training, and ensuring local QMS elements (including the Pharmacovigilance System Master File) are maintained.
• Local Legal Role: Maintains expert local knowledge and oversight of marketed product safety profiles and local studies.

Notes: The content reflects the job responsibilities and requirements as described by the employer. The text includes legal and equal opportunity statements as provided.