Pharmacovigilance Specialist (Operations Specialist 2)

MSC Quintiles Mexico S. de R.L. de C.V.; Ciudad de México; A distancia; MXN 549,000 - 916,000; Jornada completa

Descripción de la vacante

A leading global provider of clinical research services is seeking a qualified individual for a home-based role focusing on Safety data processing. The successful candidate will manage various responsibilities within Pharmacovigilance, ensuring compliance and quality while mentoring junior team members. Candidates should possess a Bachelor’s degree in Life Sciences and relevant experience in case processing.

Formación

• Up to 5 years of relevant experience, including up to 3 years of Pharmacovigilance experience in case processing.
• Proven ability to work independently and autonomously with policies and practices.
• Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients.

Responsabilidades

• Process Safety data according to applicable regulations and guidelines.
• Perform Pharmacovigilance activities per project requirements.
• Assess Safety data for reportability and report to relevant authorities.

Conocimientos

Pharmacovigilance

English (Advanced)

Project Management

Attention to Detail

Organizational Skills

Educación

Bachelor's Degree in Life Sciences

Herramientas

ARGUS Safety Database

Microsoft Office

Descripción del empleo

This is a 100% home-based role

Overview

Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium 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 perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information
• 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, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• Perform activities related 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, 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.
• Contribute knowledge and expertise to or lead 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 all project related processes and activities.
• Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
• Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
• 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 (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
• Provide effective feedback on project performance to junior members of team.
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all 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 Lead trainings across Safety process service offerings
• Participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
• 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 related 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
• Perform other duties as assigned
• 100% compliance towards all 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 Microsoft 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 IQVIA core values while doing daily tasks.
• Skill to plan workload based on available capacity and ability to change prioritization based on workload fluctuations.

IQVIA 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.iqvia.com