On behalf of our client, a European pharmaceutical company, we are looking for a successful candidate to fill the position of the Pharmacovigilance Manager position.

KEY RESPONSIBILITIES:

• Represents the local PV point of contact for communication and interactions with the Regulatory Authority in close cooperation with the respective PVWG chairperson.
• Responsible for the management of PV-relevant information received locally. Implements activities to enhance PV compliance culture and PV awareness at the local level of the organization in line with global recommendations.
• Pharmacovigilance System Master File maintaining.
• Management & execution of QPPV tasks, including but not limited to RMP, SDEA, labeling updates, and PSMF.
• Individual Case Safety Report processing, Aggregate Reports (DSUR/PSUR) management.
• PV Quality and Compliance Insurance. Audit/inspection excellence.
• Devising and establishing processes and procedures, CAPA management & process Improvement, PV Vendors management.
• Maintains appropriate PV knowledge to ensure that the Company fully complies with PV-relevant regulations in the respective territory.
• Gives PV input to local / Regional innovative drug development and marketing activities.
• Regularly updates the local Leadership team about the performance of the local PV system and proactively escalates any issue.
• Manages local Pharmacovigilance Agreements in cooperation with Global Partner Management.
• Contributes to the PV Quality system.

REQUIRED QUALIFICATION & BACKGROUND:

• Pharmaceutical or Medical degree.
• Over 5 years of leadership/management experience for LPVM with line management of a local PV team.
• Experience working in a diverse fast-paced environment.
• Excellent knowledge of relevant Pharmacovigilance regulations, legislation, and GCP, and technical knowledge of drug safety databases regarding submissions and safety information exchanges.
• Ability to work independently and as part of a team.
• Advanced English is a must.

COMPANY OFFERS:

• Competitive remuneration and a corporate bonus scheme.
• Insurance.
• Corporate car and other needed tools for comfortable work.
• Professional development and opportunity to realize your potential in a flexible, friendly global working environment.