Safety Aggregate Report, Manager
Location: Thāne, India
Job Type: Full Time
Job ID: R1474114
Job Description
IQVIA is seeking a Safety Aggregate Report, Manager to act as a stand-alone global functional lead, overseeing the Safety Aggregate Report and Analytics (SARA) Center deliverables. This includes safety aggregate reports, signal management activities, literature surveillance, and benefit-risk management documents. The Manager will collaborate with the safety customer delivery management team and ensure that teams follow best practices for safety aggregate reporting.
Key Responsibilities
Global Lead: Serve as the lead for aggregate reporting, signal management, or literature surveillance projects.
Report Management: Lead, author, and finalize safety aggregate reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, and ACOs.
Signal Management: Lead safety management teams, implement signaling strategies, and perform signal detection activities for proactive identification of risks.
Literature Surveillance: Conduct ongoing literature safety surveillance for marketed and investigational products and assist with identifying ICSRs.
Regulatory Inquiries: Author and respond to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
Team Leadership: Provide mentorship, training, and consultation to internal and external stakeholders.
Audits and Inspections: Participate in internal and external audits, ensuring project readiness and compliance with SOPs.
Process Improvements: Contribute to continuous process improvements across all SARA center services and identify efficiencies.
Reporting and Metrics: Provide regular reports on project metrics, changes in Statement of Work (SOW), and client requests.
Collaboration: Work across departments like Regulatory Affairs, Medical Writing, Clinical Research, Quality, and more to ensure project success.
Qualifications
Education: Bachelor's Degree in a Scientific or Healthcare discipline (Required).
Experience: 2-3 years of relevant work experience (Preferred).
Skills:
Extensive knowledge of Lifecycle Safety processes and governing safety regulations (Advanced).
Familiarity with GCP, GVP, ICH guidelines, and relevant SOPs (Advanced).
Strong organizational, time management, and project management skills (Advanced).
Excellent communication, report writing, and leadership abilities (Advanced).
Ability to manage competing priorities and meet strict deadlines (Advanced).
Proven mentoring and decision-making capabilities (Advanced).
About IQVIA
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. Our goal is to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.
Location: Thāne, India
Worker Type: Full Time
IQVIA is an equal opportunity employer, committed to diversity and inclusion.
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