Deputy Local Qualified Person for Pharmacovigilance (LQPPV)

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Job Description

OBJECTIVES/PURPOSE:

• Manage the Pharmacovigilance (PV) relationship within the local operating company (LOC) to provide the best PV support for the LOC.
• Collaborate and liaise with PSPV-AM and other PSPV functions to ensure appropriate systems/processes are in place to support the local PV system.
• Provide functional expertise in pharmacovigilance and support to LOCs.
• In partnership with PSPV-AM, define and implement local PV strategies as appropriate.

RESPONSIBILITIES:

The Deputy LQPPV will comply with all LQPPV responsibilities in its absence. The LQPPV and Deputy LQPPV must guarantee compliance with the following activities:

• Create and maintain a system to collect, process and evaluate the information related to all suspected adverse reactions reported to company personnel.
• Notification of suspected adverse reactions, meeting local health authority timelines.
• Preparation and/or review of periodic safety reports.
• Preparation and/or review/adaptation of risk management plans.
• Respond in a timely manner any information request from competent authorities related to medication safety matters.
• Continuous evaluation of risk-benefit balance during post-authorization period, and immediate communication to competent authorities of any information that could lead to a change to said relation.
• Ensure the necessary mechanisms to comply with the regulatory measures stablished for the medications for which pharmacovigilance is responsible, as well as all those measures and studies included in the risk management plans and that are planned to be carried out in the country.
• Set up identification and seriousness assessment criteria of alert signals.
• Periodic review of scientific literature on suspected adverse reactions of the active pharmaceutical ingredients for which the company is owner.
• Act as point of contact for PV inspections conducted in the country.
• Support in PV audits and inspections, including the follow-up of corrective and preventive actions.

EDUCATION, COMPETENCIES AND BEHAVIORAL SKILLS:

• Health professional or life science degree.
• Bachelor's degree required. An advanced degree is preferred.
• Relevant experience in the pharmaceutical or healthcare-related industry is required.
• Advanced experience in PV related areas, preferably at local, regional and/or global level.
• Advanced experience of working cross-functionally.
• Understanding of medical/scientific terminology.
• Excellent oral/written communication skills (local language and English) and experience working in virtual teams.
• Excellent knowledge of PV regulations for the global marketing environment and applicable legislation.
• Accuracy and attention to detail.
• Flexible mindset.
• High degree of cross-cultural awareness.
• Team worker with a collaborative approach.
• Ability to prioritize under pressure.
• Well-developed organizational skills.
• High level of computer skills

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