National Contact Pharmacovigilance Manager

To receive adverse events (safety issues in animals, reported violations of approved MRL, environmental problems, transmission of infectious agents, SLEE) and to handle them in collaboration with Corporate PhV.

To ensure that all PhV reports and any information from authorities regarding product PhV are promptly transmitted to Corporate PhV.

Where delegated from corporate PhV, to perform data entry and case management including causality assessment, prepare PSURs, overview the safety profiles and emerging safety concerns on designated products. Delegation is to designated personnel.

To ensure training for all the affiliate employees likely to receive or process safety reports including developing nation procedures where required. · To archive where required by national regulatory requirements.

Responsible to maintain local processes & traceability

Develop & improve local procedures. Actively participate and direct industry association working groups to anticipate and influence changes which affect the pharmacovigilance regulations.

Responsible to address Corrective Action Plans in order to fulfil global/ local requirements for inspection/ audit readiness.

Ensure to promptly transmit to Corporate PV any request for information from Authorities regarding pharmacovigilance. Provide information to regulators as required and aligned with the head of PV