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Safety Associate
2 weeks ago
Job Overview
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Essential Functions
- To Prioritize and complete the 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.
- Creating, maintaining and tracking cases as applicable to the project plan.
- Identify quality problems, if any, and bring them to the attention of a senior team member.
- To demonstrate problem solving capabilities.
- To mentor new teams members, if assigned by the Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes
- Perform other duties as assigned.
**Qualifications**:
- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
- An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req
- Good knowledge of medical terminology. Intermediate
- Working knowledge of applicable Safety Database. Beginner
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner
- Excellent attention to detail and accuracy. Beginner
- Strong organizational skills and time management skills. Beginner
- Strong verbal/written communication skills. Intermediate
- Self-motivated and flexible. Intermediate
- Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
- Ability to multi-task, manage competing priorities and deadlines. Beginner
- Ability to delegate to less experienced team members. Beginner
- Willingness and aptitude to learn new skills across Safety service lines. Beginner
- Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner
- Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner
- Ensure quality of deliverables according to the agreed terms. Beginner
- Demonstration of IQVIA core values while doing daily tasks Beginner
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner
- Regular sitting for extended periods of time. Beginner
- May require occasional travel. Beginner
- Flexibility to operate in shifts. Beginner