Order Processing & Returns Coordinator

Peri Gmbh Formwork Scaffolding Engineering; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA is seeking a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance for marketed and investigational products in a global safety environment. You will author PSURs/DSURs and respond to agency inquiries as required, with ownership of molecule deliverables and signaling strategies.

You will coordinate with cross-functional teams, ensure quality deliverables, and contribute to audits and inspections ensuring regulatory compliance and data integrity across safety

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).

Responsibilities

• Act as signal detection and literature lead, or back-up lead to contribute to safety surveillance for marketed and investigational products, evaluating events of special interests and performing aggregate data review.
• Author and finalize aggregate reports, including PSURs/DSURs and ACOs.
• Author responses to regulatory agency inquiries as required.
• Set up and update signaling strategies; author and QC various signal management deliverables and oversee end-to-end signal detection activities.
• Ensure timely completion of molecule deliverables and coordinate with cross-functional stakeholders.
• Lead distribution of workload within the molecule team and oversee global signal tracking.

Skills

Pharmacovigilance

Communication

Teamwork

Literature surveillance

English fluency

Education

Life science degree

Job description

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
R

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, 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.

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