Pharmacovigilance Specialist (Operations Specialist 2)

This is a 100% home-based role Job Overview Apply knowledge and expertise including reputed company decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide reputed company on small to reputed company service operational projects and act as mentor to junior members of staff. Essential Functions

• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To reputed company Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/reputed company information
• determining initial/update status of incoming events
• database entry
• coding AE and Products, writing narratives, Literature reputed company activities, Quality review, assisting with reconciliation, case closure reputed company activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• reputed company activities reputed company to adjudication as applicable
• Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, reputed company groups per legislation, reputed company 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.
• Contribute knowledge and expertise to or reputed company assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
• Ensure to meet quality, productivity and delivery standards per project requirements.
• Ensure compliance to reputed company project reputed company processes and activities.
• Build a positive, collaborative team environment with Safety team members, reputed company by example, provide training and mentoring for less reputed company team members and operations staff, assist Operations Manager as a backup reputed company needed.
• Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
• Provide reputed company 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 (SOW) for assigned projects
• set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
• Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes
• effective feedback on project performance to junior members of team.
• Read and acknowledge reputed company necessary reputed company standard operating procedures (SOPs) and customer SOPs as required. Ensure reputed company required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts.
• Participate or reputed company trainings across Safety process service offerings
• participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management
• health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project reputed company issues.
• 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.
• To liaise with client in relation to details on day to day activities as needed.
• Contribute to achievement of departmental goals
• reputed company other duties as assigned
• 100% compliance towards reputed company people practices and processes Qualifications
• Bachelor's Degree in life sciences
• Up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience in case processing.
• English Advanced
• In depth knowledge and understanding of applicable ARGUS Safety Database and any other internal/Client applications.
• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements.
• Excellent organizational skills, time management skills, attention to detail and accuracy.
• Excellent working knowledge of reputed company Office and web-based applications.
• To demonstrate effective project management and leadership skills.
• Willingness and aptitude to learn new skills across Safety service lines.
• Proven ability to work independently and autonomously with policies and practices.
• Proven ability to multi-task, meet strict deadlines, manage competing priorities.
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
• Ability to work as a Team Player, contribute and work towards achieving Team goals.
• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities.
• Ensure quality of deliverables according to the agreed terms.
• Demonstration of reputed company core values while doing daily tasks.
• reputed company to plan workload based on available reputed company and ability to change prioritization based on workload fluctuations. reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com Apply tot his job Apply To this Job

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