Global Drug Safety Lead position – MAT COVER – 12 month contract
Nicholas Howard Ltd are delighted to be recruiting for a Global Drug Safety Lead for a Global Pharmaceutical company based in Milan, Italy.
- Under the leadership of the Head South EMEA Drug Safety, to set up and maintain an efficient local pharmacovigilance (PV) system in compliance with the national regulations for Human medicinal products and with the Pharmacovigilance procedures for the countries in the South EMEA cluster.
- To support appropriate contacts with relevant internal local interfaces in South EMEA, such as Regulatory Affairs, Quality Assurance, Commercial, Legal, Medical Information.
- To answer any pharmacovigilance related enquiries from external customers, such as health care providers or patients.
- To immediately notify EUQPPV and GDS of any potential safety concerns including potential disruption of the PV-system and measures taken, followed by regular updates on the resolution
- To ensure the adequate and timely FUP of all adverse events within area of responsibility from all sources including reports related to pregnancy, breastfeeding, lack of efficacy, suspected transmission of infectious agents, overdose, abuse, misuse and medication errors. To support the local organizations by providing pharmacovigilance expertise in the daily routine work and supervise and coordinate operational safety tasks.
- To answer PV-related questions from the health care professionals or other stakeholders, in liaison with the EUQPPV and GDS, where necessary.
- To monitor the submission compliance to the local CAs according to the national regulations as applicable.
- To communicate any authority enquiries in a timely fashion to local/regional/global stakeholders and to provide answers to authorities in collaboration with EUQPPV and GDS.
- To monitor all Southern EMEA local Pharmacovigilance related regulations and trends and inform EUQPPV and GDS of any new changes with impact on the PV-system. To support the establishment and maintenance of an adequate Southern EMEA region local PV system on a local level in cooperation with GDS and the EUQPPV.
- To ensure local preparedness for any Authority PV inspections in cooperation with GDS and the EUQPPV for Southern EMEA region as well as any coordination activities during and after inspections.
- To support the PV parts of any Internal or Partner audits in the cluster (pre-and post-audit activities).
Education and Experience Requirements
- The function requires a relevant degree in Life Sciences.
- Professional experience of 1-3 years in Pharmacovigilance.
- Practical PV experience from several countries within a PV System is desirable.
- Good English level (minimum B1)
- Good understanding of existing local and EU regulations.
- Excellent understanding of relevant SOP’s.
- Excellent knowledge of products.