Our customer is a Multinational company leader in the production and distribution of equivalent drugs (ethical and hospital) and consumer products, we have been charged to recruit for the italian branch active in the distribution of its products to the Pharmacies and Hospitals channel, the following professional figure:

REGULATORY AFFAIRS, PHARMACOVIGILANCE & QUALITY ASSURANCE MANAGER

Reporting to the Country Head and in direct contact with Corporate Regulatory, the figure we are looking with the support of a small team, will be responsible for all activities concerning Regulatory, Pharmacovigilance & Quality and in details:

Regulatory

• Direct contact with Italian Health Authorities
• Lead regulatory activities for Company existing and future portfolio, assure the right regulatory strategies and communication
• Represent the Company in front of local authorities
• Price & Reimbursement applications and negotiation

Pharmacovigilance

• Receive reports and take down on adverse events
• Communicate requests and information related to pharmacovigilance/drug safety/risk-benefits
• Inform the QPPV of audits and inspections and assist during inspections

Quality

• Responsible for commercial quality matters
• Ensure the main quality activities: final batch release, approval of Technical Agreements ensuring application of GMP, support to global QA for Audits, recall and complaints management

Skills to cover the position:

• Degree in technical scientific disciplines (Pharmacy, CTF, Biology, Chemistry)
• Previous experience in a similar position matured in distribution companies in the pharmaceutical sector
• Good knowledge of IT tools, particularly Office
• Fluent knowledge of english language
• Good acknowledgement on European and National legislation
• High level of proactivity, flexible to handle conflicting situation, good people management, strong inclination to problem solving and decision making complete the profile.

The company offers a position in the management Team in an international environment, level and salary will be commensurate with the actual experience and skills

Job site: North- West Milan

To apply to the offer, we invite interested people (L.903/77) to send their detailed curriculum to: selezione1@hrexecutive.it , specifying their consent to the processing of personal data (art. 13 reg. UE 2016/679) and ref. HRMM81 in the subject of the email.