External job description
*job overview*
*key responsibilities*
- process safety data as per regulations, guidelines, sops, and project requirements.
- perform pharmacovigilance activities, including collecting and tracking incoming adverse events (ae)/endpoint information, database entry, coding ae and products, writing narratives, and more.
- assess safety data for reportability to relevant authorities and report within timelines.
- contribute to or lead deliverables in the field of safety publishing, risk management, safety surveillance, and medical information.
- ensure quality, productivity, and delivery standards are met.
- build a positive team environment, provide training and mentoring for less experienced team members.
- provide technical and process information to safety management and operational team on project-specific issues.
- maintain a thorough understanding of project protocol, therapeutic indication, budget, and scope of work (sow) for assigned projects.
- attend project team meetings and provide regular feedback/inputs to operations team manager on operational project metrics, challenges, and successes.
- contribute to the achievement of departmental goals.
*qualifications*
- bachelor’s degree in a scientific or healthcare discipline or allied life sciences.
- up to 4 years of relevant experience, inclusive of up to 2 years of pharmacovigilance experience.
- excellent knowledge of medical terminology.
- excellent organizational skills, time management skills, attention to detail, and accuracy.
- proven ability to work independently and autonomously with policies and practices.
- ability to work effectively on multiple projects simultaneously, organize own workload, and effectively manage teams’ priorities.
- flexibility to operate in shifts.
Li-remote