Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2)

IQVIA; Lisboa; Presencial; EUR 60 000 - 80 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Pharmacovigilance professional to lead signal detection activities and contribute to the safety surveillance of marketed and investigational products. Location includes Lisbon, Portugal and global scope.

You will author and QC aggregate safety reports (PBRERs/PSURs/DSURs/ACOs), respond to regulatory inquiries, and ensure timely delivery of molecule deliverables while maintaining strict SOP adherence.

Qualificações

• Life science qualification or related pharmacovigilance experience or education.
• 4-6 years of pharmacovigilance experience including drug safety and aggregate reports.
• Excellent written and verbal English; strong teamwork and collaboration.

Responsabilidades

• Act as signal detection and literature lead for pharmacovigilance activities.
• Author and finalize aggregate safety reports (PBRERs/PSURs/DSURs/ACOs).
• Respond to regulatory agency inquiries (PRAC) as required.
• Ensure timely completion and quality of molecule deliverables with KPI adherence.
• Coordinate with cross-functional teams and stakeholders; participate in audits/inspections.
• Adhere to IQVIA SOPs and complete required trainings.

Conhecimentos

Communication skills

Teamwork

English fluent

Formação académica

Life science qualification or pharmacovigilance experience

Descrição da oferta de emprego

Belgrade, Serbia

Lisbon, Portugal

Bloemfontein, South Africa

Zagreb, Croatia

Athens, Greece

Centurion, South Africa

Sofia, Bulgaria

Evosmos, Greece

New Cairo, Egypt

Bellville, South Africa

Full time

R1534119

Duties/Responsibilities:

• 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 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, 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

• Team working

• English - fluent (spoken, written)

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