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Urgent! Safety Aggregate Report Specialist 2 Job Opening In Bengaluru – Now Hiring IQVIA India
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products.
Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects.
Set-up, implement, organize (including documentation) and lead safety management teams.
Set-up and update products' signaling strategies.
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 characterisation of risks .
Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
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 and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner.
Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
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Unlock Your Safety Aggregate Potential: Insight & Career Growth Guide
Real-time Safety Aggregate Jobs Trends in Bengaluru, India (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Safety Aggregate in Bengaluru, India using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 5205 jobs in India and 418 jobs in Bengaluru. This comprehensive analysis highlights market share and opportunities for professionals in Safety Aggregate roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! IQVIA India is currently hiring and seeking a Safety Aggregate Report Specialist 2 to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Safety Aggregate Report Specialist 2 Jobs Bengaluru.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at IQVIA India adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Safety Aggregate Report Specialist 2 Jobs India varies, but the pay scale is rated "Standard" in Bengaluru. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Safety Aggregate Report Specialist 2 typically include Occupational Health And Safety Specialists And Technicians and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Safety Aggregate Report Specialist 2 interview at IQVIA India, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the IQVIA India's products or services and be prepared to discuss how you can contribute to their success.
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