Senior Technical Writer - Dev Docs For Gaming Fintech

Aghanim, Inc.; Lisboa; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

IQVIA is seeking a Pharmacovigilance Scientist 2 in Lisbon, Portugal, to conduct signal detection and literature surveillance for marketed and investigational products. You will lead aggregate reporting activities (PBRERs/PSURs/DSURs/ACOs) and draft regulatory responses, while ensuring timely, compliant deliverables across cross-functional teams.

The role requires 4–6 years in pharmacovigilance, strong communication, and collaboration skills.

Qualifications

• 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)

Responsabilités

• 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 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.

Connaissances

Excellent communication

Team working

English fluent

Formation

Life science degree or related qualification

Description du poste

Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2)

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
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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 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