Associate Specialist, Pharmacovigilance (Contract)

Associate Specialist, Pharmacovigilance
(6 months 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

About the role:
The Associate Specialist, Pharmacovigilance (PV) is responsible for undertaking specified PV activities (as delegated/assigned by their manager) and with oversight by their manager or a designated PV colleague. The Associate Specialist, PV is responsible for ensuring adherence to all applicable regulations, company policies and procedures.

Primary Responsibilities:

• Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.
• Assists with day-to-day adverse events case management which may include case intake (where needed), translations (as applicable), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.
• Supports local PV audits and inspections when requested.
• Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.
• Supports development and maintenance of local PV procedures and controlled documents.
• Supports PV self-inspections as required by PV Legislations (where applicable).
• Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.
• May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
• Support local implementation of applicable business continuity plans.
• Translates or quality control (QCs) translation of applicable PV documents.
• Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.
• Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
• Responsible for completing all required/applicable training assigned at time of hire and after hire, by the due dates and before performing the activity.

Requirements:

• Diploma or bachelor’s degree in life science or any other relevant field
• At least 1 year of regulatory affairs or pharmacovigilance experience
• Proficiency in Microsoft tools such as Excel and PowerPoint
• Attention to details and proactive
• Good communication skills

Reg No: R22104540
EA License no: 94C3609