Emea Signal Detection & Pharmacovigilance Scientist Ii/Iii

Iqvia; Viseu; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

IQVIA is seeking a signal detection and literature lead within our Pharmacovigilance team in Portugal. You will oversee end-to-end signal management, author aggregate reports, and respond to regulatory inquiries, ensuring compliance with KPI and QA standards.

You will lead molecule-specific work streams, set up signaling strategies, coordinate with cross-functional teams, and drive timely delivery of safety deliverables across PBRER/PSUR/DSUR programs while maintaining high data integrity.

Qualifikationen

• 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

Aufgaben

• Act as signal detection and literature lead, or back-up lead to contribute to ongoing literature safety surveillance for marketed and investigational products
• Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs
• Author responses to regulatory agency inquiries as required
• Set-up and update signaling strategies and authoring/review of signal management deliverables
• Lead ongoing signal detection activities, conduct signal validation/evaluation analyses
• Ensure documentation and tracking of signals across the life-cycle
• Coordinate with portfolio clinical science scientists and cross-functional stakeholders
• End-to-end molecule work oversight and responsibility for deliverables
• Participate in audits and ensure SOP adherence

Kenntnisse

Pharmacovigilance

Signal detection

Aggregate reports

Leadership

Ausbildung

Life science degree

Post-graduate pharmacovigilance

Jobbeschreibung

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, evaluating events of special interests as well as aggregate data review

Author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs and ACOs.

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

Can 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 updateproducts' 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, as approved by the customer's Safety Strategy Lead. Responsible for full documentation and tracking of signals.

Ensuring the completion of molecule deliverables on time and liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders.

Distribution of 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.

End-to-end molecule work oversight and responsibility (i.E., ensuring consistent tracking of signals from detection to assessment to inclusion in aggregate reports).

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

Oversight and responsibility of quality-of molecule deliverables to the customer's molecule team, with "hands-on" involvement, i.E., involved in authoring DSR conclusion, participating in SD/Lit meetings between service provider and customers.

Responsible for resolution of issues on molecule deliverables (if necessary, in collaboration with service provider process lead).

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. Ensure all required training is executed in a timely fashion to maintain compliance and documented

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.Iqvia.Com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.

All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled