# Safety Aggregate Report and Analytics (SARA) Center Global Functional Lead

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Belgrade-Serbia/Safety-Aggreg-Report-Mng--Senior-PV-Scientist_R1570557?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_2e18e042-488

## Description

As a stand-alone global functional lead at a project level, you will apply your experience, knowledge, and expertise to Safety Aggregate Report and Analytics (SARA) Center deliverables, including safety aggregate reports, literature surveillance, signal management activities, and benefit-risk management documents.

You will actively contribute to Lifecycle Safety global process initiatives and work closely with the safety customer delivery management team regarding project/client initiatives.

Key responsibilities:

- Serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects

- Lead, author, and finalize aggregate reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries

- Conduct ongoing literature safety surveillance for marketed and investigational products

- Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects

- Oversee/conduct ongoing signal detection activities, perform signal validation, and signal evaluation analyses

- Provide training to SARA staff for qualification on SARA deliverables

- Perform quality checks of all assigned SARA deliverables

- Provide consultative guidance to internal and external stakeholders for all SARA deliverables

- Act as mentor to and coach project team staff and direct line reports

- Interface with clients and other functional groups within Lifecycle Safety and other business units

- Participate in internal and external audits, as required

- Lead functional team and contribute to achievement of departmental goals

- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required

Requirements:

- Life science graduate/post-graduate, pharmacy, nursing, or other healthcare-related qualification or experience in pharmacovigilance

- 5-10 years of relevant experience in Pharmacovigilance, including hands-on experience of drug safety, aggregate reports, signal detection/signal management

- Excellent communication (written and verbal) skills

- Strong organizational and time management skills, with the ability to meet strict deadlines

- Manage competing priorities and ability to be flexible and receptive to changing demands

- English – fluent (spoken, written)

## Skills

### Required
- Pharmacovigilance
- Drug Safety
- Aggregate Reports
- Signal Detection
- Signal Management
- Literature Surveillance
- Benefit-Risk Management

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