Senior Pharmacovigilance Scientist - Aggregate Reports Lead

Aosis; Wes-Kaap; On-site; ZAR 600,000 - 900,000; Full time

Job summary

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 development and commercialization of innovative medical treatments to help improve patient outcomes.

IQVIA seeks a Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) to lead signal detection, aggregate reporting and regulatory inquiries, coordinating deliverables across

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 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/PRAC inquiries, as required.
• Quality oversight of molecule deliverables and signaling strategies across teams.
• Coordinate cross-functional stakeholders and ensure on-time molecule deliverables.

Skills

Excellent communication

Teamworking

English fluent

Education

Life science degree

Pharmacovigilance background

Job description

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 development and commercialization of innovative medical treatments to help improve patient outcomes.

IQVIA seeks a Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) to lead signal detection, aggregate reporting and regulatory inquiries, coordinating deliverables across