Pharmacovigilance (PV) Specialist
Pharmacovigilance (PV) Specialist
Objective:
The Specialist, PV is responsible for PV activities (as delegated/assigned by their manager) which may include but is not limited to PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with minimal supervision.
The Specialist, PV may serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they may manage day-to-day PV activities and serve as their back-up.
Duties and Responsibilities:
- Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.
- Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
- May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).
- Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.
- Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data.
- May support PV Lead in maintaining the local PV Training matrix and onboarding plans.
- Supports PV self-inspections as required by PV Legislations (where applicable).
- Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates.
- Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).
- May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
Education:
- Medical background degree.
Work Experience:
- Experience in the pharmaceutical industry is preferred.
- General knowledge of AE reporting requirements and relevant PV regulations is preferred, but is not required.
Job-specific competencies & skills:
- Must be fluent in English (written and spoken) while professional in local language (Arabic and French).
- At least one year of pharmacovigilance experience.
- Strong communications, organizational, and time management skills.
- Ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently.
- Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and/or add value to the business.
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