# Pharmacovigilance Scientist

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

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Belgrade-Serbia/Pharmacovigilance-Scientist-2--Safety-Aggregate-Report-Specialist-2-_R1534119-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f6b55a03-cd5

## Description

We are seeking a Pharmacovigilance Scientist to act as signal detection and literature lead, or back-up lead, to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products.

Responsibilities:

- Evaluate events of special interests as well as aggregate data review

- Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs

- Author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required

- Serve as principal owner (molecule lead) for the molecule and have responsibility for completion of the deliverable and in compliance with all applicable Key Performance Indicators (KPI)

- Set-up and update products' signaling strategies, as approved by the customer’s Safety Strategy Lead

- Author and/or QC review all types of signal management deliverables

- Lead/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks

- Ensure full documentation and tracking of signals

- Liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders

- Distribute molecule work within team consisting of molecule scientists, when necessary, coordinating support across molecules and disease areas when there are peaks and troughs in workload

- Oversee end-to-end molecule work and ensure consistent tracking of signals from detection to assessment to inclusion in aggregate reports

- Ensure an in-depth knowledge of the molecule and disease area within the service provider molecule team

- Oversee and be responsible for the quality of molecule deliverables to the customer’s molecule team

- Participate in internal and external audits and inspections, as required

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

- Conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members

Qualifications:

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

- 4-6 years of relevant experience in Pharmacovigilance including hands-on experience of drug safety, aggregate reports, signal detection/signal management preferred

- Excellent communication (written and verbal) skills

- Team working

- English – fluent (spoken, written)

## Skills

### Required
- Pharmacovigilance
- Signal Detection
- Aggregate Reports
- Regulatory Compliance
- Communication

### Nice to have
- Drug Safety
- Signal Management
- Team Working
- English Language

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Belgrade-Serbia/Pharmacovigilance-Scientist-2--Safety-Aggregate-Report-Specialist-2-_R1534119-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)