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Case Management QA Vendor Associate Job Opening In India, India – Now Hiring Confidential


Job description

  • Support interactions with business partners (license partners) and vendors for all case intake and processing activities.
  • Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures.
  • Ensure vendor compliance with approved processes and training requirements.
  • Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors.
  • Act as US/EU local safety office and FDA/EMA point of contact for safety reporting.

    Provide audit & external inspection support.
  • Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
  • Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
  • Provide vendors with resources and training to perform their role
  • Analysis and communication of case Quality Control results
  • Responsible for escalation of case related issues from vendor(s)
  • Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
  • Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
  • May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
  • Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
  • Ensure vendor case processing timelines for AE intake, triage and submission are met
  • Perform retrospective quality assurance of vendor processed cases
  • Day-to-day vendor management issues
  • Interact with other local safety offices as applicable
  • Support on-boarding and off-boarding of vendor staff
  • Attend management meetings with vendors
  • Support analysis of QC trends
  • Support generating, communicating, and archiving of reports of QC findings
  • Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
  • Perform case review as required
  • Generate and distribute performance metrics (retro QA / Case correction)
  • Support analysis of QC trends including actions/recommendations

What we expect of you 

We are all different, yet we all use our unique contributions to serve patients.

The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

  • Doctorate degree and 3 years of directly related experience (OR)
  • Master's degree and 6 years of directly related experience (OR)
  • Bachelor's degree and 8 years of directly related experience (AND)
  • 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Skills:

Understanding of global regulatory requirements for pharmacovigilance

Proficiency in safety case processing

Expertise in all aspects of case intake and processing in multiple global safety databases

Experience in supporting inspections or internal audits

Communication skills and attention to detail


Skills Required
Qa, Case Processing, Vendor Management, Automation Testing, Software Testing

Required Skill Profession

Business Operations Specialists


  • Job Details

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Unlock Your Case Management Potential: Insight & Career Growth Guide


Real-time Case Management Jobs Trends (Graphical Representation)

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The Work Culture

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 Confidential adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying India laws and regulations

What Is the Average Salary Range for Case Management QA Vendor Associate Positions?

The average salary range for a varies, but the pay scale is rated "Standard" in India. 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.

What Are the Key Qualifications for Case Management QA Vendor Associate?

Key qualifications for Case Management QA Vendor Associate typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

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Interview Tips for Case Management QA Vendor Associate Job Success

Confidential interview tips for Case Management QA Vendor Associate

Here are some tips to help you prepare for and ace your Case Management QA Vendor Associate job interview:

Before the Interview:

Research: Learn about the Confidential's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

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Follow Up: Send a thank-you email to the interviewer within 24 hours.

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Turn Off Phone: Avoid distractions during the interview.

Final Thought:

To prepare for your Case Management QA Vendor Associate interview at Confidential, 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 Confidential's products or services and be prepared to discuss how you can contribute to their success.

By following these tips, you can increase your chances of making a positive impression and landing the job!

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