Enthusiastic drug safety professional eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow and excel in pharmacovigilance. In depth knowledge and understanding of global, regional, and local clinical research regulatory requirements as well as knowledge of applicable Safety Databases and other internal/Client applications. Excellent reputation for resolving problems and improving customer satisfaction with experience in clinical trial and post-marketing studies.
· Excellent organizational and time management skills with attention to detail.
· Proven ability to work independently and autonomously with policies and practices.
· Proven ability to multi-task, meet strict deadlines, manage competing priorities.
· Willingness and aptitude to learn new skills across Safety service lines.
· Ability to identify, prioritize tasks and delegate to team members.
· Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams' priorities.
· Excellent working knowledge of Microsoft Office, Excel, and Powerpoint.
· Safety Database Argus 8.1.2, clinical database InForm 6.1 and Rave
· Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
· Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information, and determining initial/update status of incoming events
· Database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, and coordinating translations, as per internal/ project timelines.
· Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
· Liaise with manager for regulatory tracking requirements and electronic reporting.
· Ensure to meet quality, productivity and delivery standards per project requirements.
· Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
· Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work for assigned projects
· Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
· Effective feedback on project performance to junior members of team.
· Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.
· Liaise with client in relation to details on day to day activities as needed.
· Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.
· Analyzes caller's questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.
· Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.
· Maintains thorough knowledge of project and corporate policies and procedures including client products, SOP's, protocols, GCP's, and applicable regulatory requirements.
· Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries. As needed, researches medical literature and drafts responses for such inquiries.
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