Safety Aggregate Report Specialist 2
7 days ago
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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Safety Aggregate Report Spec 1
1 week ago
Bengaluru, Hyderabad, Kolkata, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per yearProject role : Safety Aggreg Report Spec 1Work experiences : 2 to 6 years.Work location : HybridMust have skills : "Aggregate Report", PBRER, PSUR, DSUR, PADER, "Signal Management", "Signal Detection"Essential Functions :Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device...
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Safety Aggreg Report Spec 2
21 hours ago
Bengaluru, Karnataka, India IQVIA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob OverviewApply 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 FunctionsServe as principal owner of the SARA deliverable and have responsibility for completion of the...
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Medical Writer- Aggregate Reporting
4 weeks ago
Bengaluru, India Theron Solutions Full timeJob Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for...
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Medical Writer- Aggregate Reporting
3 weeks ago
Bengaluru, Karnataka, India, Karnataka Theron Solutions Full timeJob Insights:Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety teamResponsibilities:Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.Responsible for end-to-end...
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Bengaluru, India Theron Solutions Full timeJob Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end...
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▷ Apply Now: Medical Writer- Aggregate Reporting
3 weeks ago
Bengaluru, India Theron Solutions Full timeJob Description Job Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: - Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. -...
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Senior Medical Writer, Safety Reports
3 weeks ago
Bengaluru, India Theron Solutions Full timeJob Insights:Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety teamResponsibilities:Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.Responsible for end-to-end...
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Medical Safety Writer
5 days ago
Bengaluru, India Alcon Full timeSummary of Position: - Alcon is looking to hire Medical Safety Writer to join our Medical Safety Writing team at Bengaluru in India. This role will Support Global Medical Safety in preparation of regulatory safety documentation and ensure the safety documents comply with applicable standards and regulations across region_ Key Responsibilities: - Act as...
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Medical Safety Writer
7 days ago
Bengaluru, India Alcon Full timeSummary of Position: - Alcon is looking to hire Medical Safety Writer to join our Medical Safety Writing team at Bengaluru in India. This role will Support Global Medical Safety in preparation of regulatory safety documentation and ensure the safety documents comply with applicable standards and regulations across region_ Key Responsibilities: - Act as...
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Safety Specialist I
1 week ago
Bengaluru, Karnataka, India Precision Value & Health Full time ₹ 5,00,000 - ₹ 12,00,000 per yearSafety Specialist I -Location: Bangalore Karnataka IndiaBangalore Karnataka IndiaJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 6002Position SummaryThe Safety Specialist I is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting...
