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Full Time
Job Summary
The SME-Pharmacovigilance role is crucial for ensuring the safety and efficacy of pharmaceutical products. The candidate will leverage their expertise in PV Case Processing and customer service to enhance pharmacovigilance operations. This position requires a proactive approach to monitoring drug safety and contributing to research and development efforts.
Responsibilities
Triage & intake of ICSRs in ARGUS databases within agreed timelines
Download and monitor valid ICSRs from Eudra Vigilance (EV)- or any other sources
Process literature, spontaneous, clinical trial, and solicited cases
Search for valid ICSRs in Literature search tools
Generate reports and submit to health authorities and business partners
Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy
Code events, indications, patient history using MedDRA
Code suspect products, amend narratives, and label events
Obtain follow-up information for all cases per applicable guidelines
Submit processed cases to regulatory authorities and distribute reports to Partners
Communicate effectively with client stakeholders and internal teams
Attend all internal and client trainings to ensure guideline compliance
Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.
Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.
Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.
Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.
Engage in rotational shifts to provide consistent support and coverage across different time zones.
Requirements
Bachelor’s / Master’s degree in pharmacy.
Minimum 3 years relevant work experience in case processing activities.
Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.
Excellent organizational and time management skills.
Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
Good knowledge of medical terminology.
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