Safety Data Specialist
4 weeks ago
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We are seeking a highly skilled Safety Data Specialist to join our team.
Salary Range: $60,000 - $80,000 per annum
About the RoleThis role is responsible for reviewing, assessing and processing safety data and information from various sources. You will work closely with internal and external teams to ensure compliance with applicable regulations and guidelines.
Main Responsibilities:
- To prioritize and complete assigned trainings on time.
- 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 as per internal/project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- 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.
To be successful in this role, you will need:
- A High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences.
- Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
- Or equivalent combination of education, training and experience.
- Good knowledge of medical terminology.
- Working knowledge of applicable Safety Database and any other internal/Client applications.
- Knowledge of applicable global, regional, local clinical research regulatory requirements.
- Excellent attention to detail and accuracy.
- Maintain high quality standards.
- Good working knowledge of Microsoft Office and web-based applications.
- Strong organizational skills and time management skills.
- Strong verbal/written communication skills.
- Self-motivated and flexible.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
- Ability to delegate to less experienced team members.
- Ability to be flexible and receptive to changing process demands.
- Willingness and aptitude to learn new skills across Safety service lines.
- 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.
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