Operations Specialist
hace 6 meses
**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 Standard Operating Procedures (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.
- 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 your individual training plan and training transcript are reconcilable.
- 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.
**Qualifications**
- 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.
- Strong organizational skills and time management skills.
- Strong verbal/written communication skills.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
- Willingness and aptitude to learn new skills across Safety service lines. Intermediate
- Ensure quality of deliverables according to the agreed terms.
- Demonstration of IQVIA core values while doing daily tasks
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time
- Flexibility to operate in shifts.
**#LI-Remote**
**#LI-MARIAARECHAGA
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