Pharmacovigilance Specialist

Randstad Italia; Caserta; Remoto; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A leading staffing agency is seeking a Pharmacovigilance Specialist to support compliance with regulatory obligations in pharmacovigilance. The role involves managing relationships with external partners and internal teams to ensure day-to-day operational support for pharmacovigilance activities. The ideal candidate will have experience in PV, strong organizational skills, and the ability to work in a remote environment.

Competenze

• Proven experience in pharmacovigilance.
• Familiarity with regulatory requirements in the EU and international territories.
• Strong communication and organizational skills.

Mansioni

• Support the International QPPV team in promoting compliance with pharmacovigilance obligations.
• Act as liaison between the Company and external pharmacovigilance service providers.
• Manage and implement change controls for PV activities.

Descrizione del lavoro

Randstad Italy, for a client company in the pharmaceutical sector, is looking for a Pharmacovigilance Specialist

Contractual Offer: 30-40K.

Working Hours: full time.

Location: remote working.

Brief Description

The role of Pharmacovigilance (PV) specialist supports the International QPPV (Qualified Persona for Pharmacovigilance Office) team to promote, maintain, and improve the applicable regulatory and legal pharmacovigilance obligations in the EU and in International Territories where the Company operates.

The role acts as the key liaison point between the Company and the external contracted pharmacovigilance services providers, providing day‑to‑day operational support for PV system oversight. It assists in collecting information on Countries, Affiliates, and PV Partners to support global expansion activities and collaborates with Global Regulatory Affairs and Drug Safety colleagues to align global expansion activities and local QPPVs with PV requirements.

Responsabilities of the position

• Ensure oversight of activities and interactions with internal departments and external business partners to support the International QPPV Office team in meetings, when required;
• Set up meetings, prepare agendas and minutes, when required;
• Provide support to Geographic Expansion activities: manage and implement change controls and action plans for PV activities, manage periodic oversight meetings with local QPPVs and PV Partners;
• Perform other Geographic Expansion-related activities, as appropriate;
• Serve as back‑up for the PV Intelligence Coordinator to support the maintenance of processes to ensure compliance with worldwide PV regulatory and legal requirements and to address any necessary changes in a timely and appropriate manner;
• Assist in coordinating the ongoing standard PV intelligence process;
• Promote awareness and contribute to continuous improvement of the PV intelligence process;
• Perform basic ad hoc PV intelligence searches to support Geographic Expansion;
• Assist in identifying actions to be implemented in the marketing authorisation pre‑submission phase and following post‑marketing authorization approval based on local PV requirements including but not limited to local Pharmacovigilance System Master File (PSMF), local Qualified Person Responsible for Pharmacovigilance (QPPV), local Risk Management Plan / periodic reports. In addition, identify actions to be implemented in marketing authorisation