Safety Aggreg Report Spec

2 days ago

Bengaluru, India IQVIA Full time

Job Overview
Manage the administrative support for deliverables across the Safety Aggregate Reporting and Analytics (SARA) services, as appropriate. SARA deliverables include safety aggregate reports, literature surveillance, signal detection and benefit risk management services.

Essential Functions
- Schedule and attend planning meetings and maintain the minutes of the meeting. Initiate and manage the workflow of controlled documents.
- Under direction of Functional Project Leads, set-up & maintain SARA services trackers for new projects, and enter, update and maintain SARA/ BRM / LR deliverables schedules for project in the designated trackers.
- Assist with metrics management, reconciliation, audit and training tasks, monitor SARA specific mailboxes and other coordinator activities as assigned.
- Prepare final formatting/compilation of document(s) including necessary attachments/appendices.
- May assist with creating project tracking spreadsheets and associated tracking entry specifications
- assisting in database validation through performance of user testing
- performing ad hoc database searches
- escalating any system/equipment problem.
- Oversee and co-ordinate administrative support by coordinating team/department/customer/project oversight group meetings & disseminating/saving meeting minutes, coordinating stationery orders, dispatching documents via courier services, reserving meeting rooms and IT equipment
- and providing administrative support where required.
- Update, maintain and organize applicable electronic file systems and SARA Sharepoint sites.
- Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
- 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 ensuring Good Documentation Practices (GDP).
- Support and/or contribute to technology / innovation activities.

**Qualifications**:

- High School Diploma or equivalent Req
- 1 to 2 years’ relevant work experience.
- Equivalent combination of education, training and experience.
- Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role.
- Good knowledge of medical terminology.
- Strong organizational skills and time management skills.
- Strong verbal/written communication skills.
- Self-motivated and flexible.
- Excellent attention to detail and accuracy.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Proven ability to multi-task, manage competing priorities and deadlines.
- Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
- Contributes in the conduct of ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.

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