Pharmacovigilance Specialist Covid Project

Pharmacovigilance Specialist 1

Job 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.

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

• 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.

• 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.

• 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 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

• Participate or Lead trainings across Safety process service offerings

• 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.

• Contribute to achievement of departmental goals

• Perform other duties as assigned

Qualifications

Full English Proficiency

100% Home based

• Desirable Bachelor's Degree Scientific or healthcare discipline

• Up to 3 years of relevant experience, in Pharmacovigilance or Clinical Trials.

• Excellent knowledge of medical terminology.

• Excellent verbal/written communication skills.

• Self-motivated, flexible, receptive to changing process demands.

• 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 work as a Team Player, contribute and work towards achieving Team goals.

• Demonstration of IQVIA core values while doing daily tasks.

• Flexibility to operate in shifts.