Pharmacovigilance Specialist

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

Descrizione del lavoro

A pharmaceutical recruitment agency is seeking a Pharmacovigilance Specialist to support their International QPPV Office. The role entails managing pharmacovigilance oversight, supporting geographic expansion activities, and assisting in audits and compliance. The ideal candidate will have experience in pharmacovigilance or regulatory affairs along with strong organizational skills. This position offers remote working opportunities.

Competenze

• 1+ years of experience as Specialist in Pharmacovigilance.

Mansioni

• Support the International QPPV Office team in meetings.
• Manage and implement change controls for PV activities.
• Assist in PV audits and inspections preparation.

Conoscenze

Strong organizational skills

Communication skills

Ability to manage multiple tasks

Willingness to learn

Formazione

Academic background in pharmacovigilance, regulatory affairs or life science

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 with the applicable regulatory and legal pharmacovigilance obligations in the EU and in International Territories where the Company operates.

The role acts ad the kay liaison point between the Company and the external contracted pharmacovigilance services providers, providing day-to-day operational support for PV system oversight assisting in collecting information on Countries, Affiliates, and PV Partners to support global expansion activities and supporting collaboration with Global Regulatory Affairs and Drug Safety colleagues to align global expansion activities and local QPPVs with PV requirements.

Responsibilities

Ensures oversight of activities and interactions with internal departments and external business partners to :

• support the International QPPV Office team in meetings, when require;
• set up meetings, prepare agendas and minutes, when required;
• provides support to Geographic Expansion activities to : management and implementation of change controls and actions plans for PV activities, management of periodic oversight meetings with local QPPVs and PV Partners;
• perform other Geographic Expansion-related activities, as appropriate;
• serves 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 transfer and / or withdrawal;
• support the review of PV agreements, highlighting where local PV requirements should be reflected within the agreements;
• serves as the PSMF Administrator / back-up for the PSMFs or equivalent documents to : act as support or back-up for the preparation and ongoing maintenance of the PSMFs or equivalent documents, and the related documentation, in accordance with the assigned schedule;
• support the ad hoc preparation of Summaries of PV system;
• help maintain the schedule of updates and data requirements for the PSMFs or equivalent documents;
• ensure the content of the PSMFs, or equivalent documents, are compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions and / or with the Local applicable PV regulations;
• ensure the content of the PSMFs, or equivalent documents, are provided in a timely manner, collating the data, resolving queries and ensuring review, approval and release of the document as appropriate and per applicable procedures;

provides support to the International QPPV Office for PV audits and inspections, including : assisting with the readiness, preparation, facilitation and follow-up of PV audits and inspections,assisting with the development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspection

Required Knowledge, Skills and Abilities

• 1+ years of experience as Specialist in PV;
• Academic background in pharmacovigilance, regulatory affairs or life science;
• Strong organizational and communication skills;

Willingness to learn and ability to manage multiple tasks in a dynamic environment.

Proficiency in Microsoft

The search is open to both male and female candidates (L.903 / 77). Please read the privacy policy pursuant to Article 13 of Regulation (EU) 2016 / 679 on data protection (GDPR) at https://www.randstad.it/privacy/