ClinChoice is Hiring Aggregate Report Physician
Job Title: Aggregate Report Physician
Employment Type: Full time
Location: Hyderabad / Bengaluru/Remote
Qualification: MBBS
Experience: 2-3 Years
Primary Responsibilities
- Responsible for reviewing/authoring of PBRER/PSUR for innovator products and devices for EMA and other local health authorities as per the requirement.
- Co-ordinate with various stakeholders and conduct planning meeting and obtain the inputs required for drafting the PBRER/PSUR reports.
- Address the comments of stakeholders and submit the clean copy of the report to Sponsor.
- Manage the production of aggregate reports such as PBRER/PSUR etc. for assigned products medium to high complexity reports.
- Perform quality reviews for the reports prepared by the peer aggregate report writers.
- Ensure preparation of timely, quality aggregate reports for assigned products.
- Liaise with relevant stake holders as appropriate for preparing report content.
- Data quality review /correction.
- Quality review of team members aggregate reports.
- Attend team meeting, department meetings, required training and relevant activities.
- Awareness of global culture and drug safety.
Secondary Responsibilities
- Complete all assigned trainings in within specified timelines within internal training tool and sponsor training tool.
- Attend team meeting, department meetings, required training and relevant activities.
- Keeping the trackers up-to-date and timely archival of documents in SharePoint.
Candidate Profile
- Should have done MBBS with or without MD.
- Good understanding of ICH E2C (R2) and GVP module 7 guidelines.
- 1-3 Years of experience on drafting of PBRER/PSUR for innovator products.
- Excellent written and verbal English communication skills.
- Competent in use of desktop applications: Microsoft Excel, Word and PowerPoint