Associate Specialist, Pharmacovigilance
12-month contract
About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission.
Responsibilities:
The Associate Specialist, Pharmacovigilance (PV) is responsible for undertaking specified PV activities including projects with oversight by their manager or a designated PV colleague.
- Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Assists with 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.
- Assists with Individual Case Safety Report (ICSR) Health Authority submissions in accordance with company procedures and health authority requirements, when requested.
- Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested.
- Responsible for filing (electronic, paper), storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports.
- Supports local PV audits and inspections when requested.
- Supports PV self-inspections as required by PV Legislations (where applicable).
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
- Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
- May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system.
- May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
- Support local implementation of applicable business continuity plans (as applicable).
- Performs other activities as requested by their Manager.
- May participate on special projects or rotational assignments within or outside of IPV as part of their professional development.
Job requirements:
- Health, life science, or medical science degree or equivalent
- At least 1 year of Pharmacovigilance (PV) experience in pharmaceutical industry
- Experience in Medical Affairs/Regulatory/Clinical research related to drugs
- Knowledge of AE reporting requirements and relevant PV regulations
Reg No: R22104540
EA License no: 94C3609
