Global Drug Safety Lead

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. Italy
Posting date: 01 Feb 2019

ProClinical is pleased to advertise an exciting vacancy for a Global Drug Safety Lead to join an international pharmaceutical organisation that focuses on developing treatments for conditions where the impact of the medicines can make an immediate and tangible difference. They provide treatments in Neuroscience, Rare Diseases and other medical sectors. This company is seeking for a Global Drug Safety Lead to come on a contract basis for their office in Milan.

Under the leadership of the company's Head South EMEA Drug Safety, the Global Drug Safety Lead (GDS) will set up and maintaining an efficient local pharmacovigilance (PV) system in compliance with the national regulations for human medicinal products and with the company's PV procedures for the countries in the South EMEA cluster.

Job Responsibilities:

  • Acting as the point of contact for the local Competent Authorities (CA) regarding any pharmacovigilance topics; providing the Cas with information concerning benefit and risk balance of company medicinal products in close cooperation with GDS and the EUQPPV and, where appropriate, with other stakeholders in a timely manner.
  • Supporting appropriate contacts with relevant company internal local interfaces in South EMEA, such as Regulatory Affairs, Quality Assurance, Commercial, Legal, and Medical Information.
  • Answering any PV related enquiries from external customers, such as health care providers or patients.
  • Supporting the EUQPPV and cooperating with other local and MEA/Global interfaces in the management of drug-related product issues, and the coordination of PV-related activities.
  • Immediately notifying EUQPPV and GDS of any potential safety concerns, including the potential disruption of the PV-system and measures taken, then regularly updating on the resolution.
  • Ensuring the adequate and timely collection, documentation, processing, and following up of all adverse events within the area of responsibility from all sources, including reports related to pregnancy, breastfeeding, lack of efficacy, suspected transmission of infectious agents, overdosing, abusing, misuse, and medication errors.
  • Supporting local organisations by providing PV expertise in the daily routine work; supervising and coordinating operational safety tasks.
  • Answering PV-related questions from the health care professionals or other stakeholders in liaison with the EUQPPV and GDS where necessary. Monitoring the submission compliance to the local Cas according to the national regulations as applicable.
  • Communicating any authority enquiries in a timely fashion to local/regional/global stakeholders, providing answers to authorities in collaboration with EUQPPV and GDS.
  • If stated in the protocol, processing the SAEs in accordance with GDS procedures.
  • Notifying/submitting the SUSARs and new events to the Health Authorities, according to the national regulations.
  • Monitoring all Southern EMEA local Pharmacovigilance related regulations and trends and informing EUQPPV and GDS of any new changes with impact on the PV system.
  • Establishing and maintain an adequate Southern EMEA region local PV system on a local level in cooperation with GDS and the EUQPPV.
  • Ensuring local preparedness for any Authority PV inspections in cooperation with GDS and the EUQPPV for Southern EMEA regions, as well as any coordination activities during and after inspections.
  • Supporting the PV parts of any Internal or Partner audits in the cluster.
  • Monitoring general PV compliance, including non-conformance reports and supporting management review meetings.
  • Supporting the EUQPPV and cooperating with other local and European/Global interfaces in the management of drug-related product safety issues and the coordination of PV-related activities, and ensuring timely communication to relevant stakeholders.

Skills and Requirements:

  • A relevant degree in a Life Sciences field
  • 1-3 years' experience in Pharmacovigilance.
  • Practical PV experience from several countries within a PV system is desirable.
  • Demonstrable understanding of existing local and EU regulations
  • An excellent understanding of relevant SOPs.
  • Proficiency in both written and oral English.
  • Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail.
  • Can conform to shifting priorities, demands and timelines.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Valeria Cardo on +44 203 854 0674 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.