Baxter Hiring For Analyst Vacancy – BSc Candidates Apply Online
Baxter Hiring For Analyst Vacancy – BSc Candidates Apply Online. Interested and eligible candidates can check out all of the details on the same below
Submission Analyst
Req # JR – 149815
Location: Bengaluru, Karnataka, India
Job Category: Patient Safety
Date posted: 12/02/2024
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics, and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful, and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Summary:
This position is a member of the Safety Submissions team within Global Pharmacovigilance and is responsible for electronic distribution and submission of individual case
safety reports (ICSRs). This includes maintaining and setting up electronic submission rules in the pharmacovigilance database.Essential Duties and Responsibilities:
- Create and issue regulatory reports, including individual case safety reports.
- Run and/or monitor electronic submissions of ICSRs to Regulatory Authorities, affiliates, or business partners as appropriate.
- Participate in peer review of submissions performed by another member of the team.
- Support the setup and maintenance of electronic submission rules and reportability by product and recipient in the pharmacovigilance database to ensure electronic reporting is performed in compliance with applicable regulations and guidelines.
- Assist in providing electronic submission intelligence to Safety Operations to facilitate proper coding of AE data. This covers ICH E2B and HL7 data standards as well as future developments in that area. For ease of reference, they are all referred to as E2B in this document.
- Assist Safety Operations in troubleshooting E2B rejections to make necessary corrections to get reports accepted by the applicable regulatory agencies.
- Interface and collaborate within the scope of these responsibilities with:
- Relevant counterparts in the regional & country pharmacovigilance functions to facilitate electronic distribution/submission to each country contact.
- Data analysts and other functions within PV Technology in all aspects of database maintenance.
- Safety Operations (document specialists, data coordinators, and safety reviewers) and other functions within Global Pharmacovigilance (GPV) to process adverse events efficiently & reliably.
- Other Baxter groups (e.g., Clinical & Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc.), specifically regarding safety data standards.
- Take initiative to recognize, prioritize, and escalate potential safety/compliance issues.
- Additional responsibilities and projects as assigned.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Solid knowledge of pharmacovigilance terminology, specifically ICH E2B, and system data entry conventions.
- Capacity to analyze & resolve problems with analytical & problem-solving skills.
- Strong organizational skills with strong attention to detail.
- Excellent written & oral communication skills.
- Operates effectively in a team environment.
- Global Safety Database knowledge.
- Solid technical system skills (e.g., word processing, spreadsheet, databases, and markup languages).
- Knowledge of medical terminology.
Education and/or Experience:
- Bachelor’s degree in computer science, life sciences, or equivalent.
- One year of previous experience in Safety Submissions or other areas of pharmacovigilance, regulatory affairs, and/or clinical research is desired.
- Additional job experience in the following areas is relevant: quality assurance, data management, or IT.
Keywords: Baxter, Submission Analyst, Patient Safety, Bengaluru, Karnataka, India, Global Pharmacovigilance, Safety Submissions. Baxter Hiring For Analyst Vacancy – BSc Candidates Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
