168 Review jobs in India

Manager, Medical Content Review & Regulatory Compliance

Vadodara, Gujarat Ortolan

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Job Description

Manager, Medical Content Review & Regulatory Compliance

Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed and detail-oriented pharmacist or physician, with experience in medical review from a healthcare compliance perspective, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

  • We act decisively but we never compromise on quality.
  • We keep our promises and do as we say.
  • We value our heritage and foster an entrepreneurial spirit.
  • We reinvest in our future - in our products, our brands and our people.
  • We give back to our communities.
  • Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.

    We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

    Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

    About the role:

    As Manager, Medical Content Review & Regulatory Compliance, you will manage the medical reviewer function for Pharmanovia, including all Medical Legal Regulatory (MLR) management together with medical and regulatory review management tasks. This is a broad ranging role requiring responsible implementation of MLR policies, systems and procedures within the global medical team.

    You will be a trained pharmacist or physician with experience in the medical review of promotional and non-promotional materials from a healthcare compliance perspective. Final signatory and certification are relevant for this role, from an EFPIA and ABPI perspective, but not essential.

    Reporting into the Medical Affairs department, you will be working as an individual contributor and act as a key member of the wider Scientific Affairs team.

    The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

    Main responsibilities & duties:

  • Performing full medical (and regulatory, i.e. against SmPC) review of promotional and non-promotional materials as well as HCP/HCO events including fair market value (FMV) assessment for disclosures (ToV)
  • Training colleagues and third parties on MLR related SOPs and processes
  • Coordinating MLR review, maintaining related SOPs (and auditing program to ensure compliance)
  • Management of potential 3rd Party Material review partner(s)
  • Implementing an internal pre-approval/reporting procedure
  • Final sign-off and certification (or willing to do so in the future)
  • Establishing and developing controls and documentation requirements
  • Collaborating with Marketing and other relevant departments to create adequate Q&As / guidance for products and materials, managing central MLR database
  • Disease area and competitors' knowledge, materials review from competitors
  • Datamining of MLR database to support various internal departments and share relevant insights
  • Maintaining a clear understanding and oversight of different MLR processes and partners within Pharmanovia's operations
  • Being a credible MLR expert in the EFPIA and ABPI environments
  • Engaging with external stakeholders to ensure a good understanding of the external environment and different stakeholder groups e.g. Health Authorities, External Experts, Associations, Patient groups, Payers, etc.
  • Please note: This is not a pharmacovigilance or medical transcription role.

    We're looking for a medically qualified professional-such as a pharmacist or physician-with proven experience in Medical, Legal, and Regulatory (MLR) review of both promotional and non-promotional materials. The ideal candidate will have worked within a global Medical Affairs or Compliance environment and is confident navigating cross-functional review processes.

    About you:

    Candidates qualified as a pharmacist or physician, with experience of medical review from a healthcare compliance perspective, should have the skills and experience required for the role. We are also looking for:

  • Pharmacy or Medical degree
  • Final signatory (or willing to become one) desirable
  • Strong understanding of EFPIA and/or ABPI codes of practice and willing to learn to fill any knowledge gaps
  • Full professional proficiency in English (written and verbal)
  • Experience in design, strategy execution and oversight of MLR process
  • Organised, inquisitive, innovative problem solvers with the ability to perceive, understand and interpret facts quickly and precisely
  • Solid time management skills, the ability to multitask and see the big picture
  • Strong technical skills
  • A resilient individual who is not afraid to challenge at all levels
  • Data driven in decision making with the ability to analyse, focus on the key issues and communicate with clarity
  • What we offer:

    We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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    Process Associate - Content Review - Punjabi + English

    Hyderabad, Andhra Pradesh Genpact

    Posted today

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    Job Description

    Ready to shape the future of work? 
    At Genpact, we don’t just adapt to change—we drive it. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges. 
    If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that’s shaping the future, this is your moment. 
    Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

    We are inviting applications for the role of Process Associate, Content Moderation - Punjabi
    We’re looking for someone with a strong work ethic, and the ability to work well both independently and within the context of a larger team-oriented environment.
    Self-starting, intellectually curious and creative individual comfortable operating in a fast-paced, dynamic environment
    Responsibilities
    • Provide resolution to maintain standards of quality
    • Review content and provide resolution based on prescribed guidelines
    • Recognize trends and patterns and raise issues timely
    • Provide insights to help improve the support to the users
    • Maintain a thorough understanding of process and policies
    • Provide excellent customer service to our customers
    • This job may require working a 24/7 schedule with alternating shifts and daily review of online content that may be highly egregious/ sensitive in nature, such as (but not limited to) graphic violence, self-harm, child abuse, and hate speech.
    Qualifications we seek in you
    Minimum qualifications
    • Any Graduate (PG an added advantage)
    • Freshers are eligible
    • Fluent in Read/Write in English & Punjabi Language

    Preferred qualifications
    • Effective probing skills and analyzing / understanding skills
    • Problem solving skills with customer centric approach
    • Must be able to work on a flexible schedule (including weekend shift work)
    Why join Genpact? 
    • Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation 
    • Make an impact – Drive change for global enterprises and solve business challenges that matter 
    • Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities 
    • Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day 
    • Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress 
    Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up. 
    Let’s build tomorrow together. 
     

    This advertiser has chosen not to accept applicants from your region.

    Process Associate - Content Review - Kannada + English

    Hyderabad, Andhra Pradesh Genpact

    Posted today

    Job Viewed

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    Job Description

    Ready to shape the future of work? 
    At Genpact, we don’t just adapt to change—we drive it. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges. 
    If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that’s shaping the future, this is your moment. 
    Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

    We are inviting applications for the role of Process Associate, Content Moderation - Kannada
    We’re looking for someone with a strong work ethic, and the ability to work well both independently and within the context of a larger team-oriented environment.
    Self-starting, intellectually curious and creative individual comfortable operating in a fast-paced, dynamic environment
    Responsibilities
    • Provide resolution to maintain standards of quality
    • Review content and provide resolution based on prescribed guidelines
    • Recognize trends and patterns and raise issues timely
    • Provide insights to help improve the support to the users
    • Maintain a thorough understanding of process and policies
    • Provide excellent customer service to our customers
    • This job may require working a 24/7 schedule with alternating shifts and daily review of online content that may be highly egregious/ sensitive in nature, such as (but not limited to) graphic violence, self-harm, child abuse, and hate speech.
    Qualifications we seek in you
    Minimum qualifications
    • Any Graduate (PG an added advantage)
    • Freshers are eligible
    • Fluent in Read/Write in English & Kannada Language

    Preferred qualifications
    • Effective probing skills and analyzing / understanding skills
    • Problem solving skills with customer centric approach
    • Must be able to work on a flexible schedule (including weekend shift work)
    Why join Genpact? 
    • Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation 
    • Make an impact – Drive change for global enterprises and solve business challenges that matter 
    • Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities 
    • Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day 
    • Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress 
    Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up. 
    Let’s build tomorrow together. 
     

    This advertiser has chosen not to accept applicants from your region.

    Data Review Associate

    Navi Mumbai, Maharashtra MEDPACE

    Posted today

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    Job Description

    Overview

    Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

    Why Medpace?

    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

    The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

    Medpace Perks

  • Flexible work environment 
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
  • This advertiser has chosen not to accept applicants from your region.

    Medical Content and Review Specialist

    Pune, Maharashtra EVERSANA

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    Job Description

    Job Description

    THE POSITION :

    The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published. The MLR process must rigorously control and execute review, approval and document filing actions. As part of the MLR team, the Medical Content and Review Specialist is responsible for managing all the MLR process for a dedicated client. The Medical Content and Review Specialist ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations.

    ESSENTIAL DUTIES AND RESPONSIBILITIES:
    Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

    MEDICAL CONTENT AND REVIEW SPECIALIST RESPONSIBILITIES

  • Manages the end-to-end MLR process.
  • Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
  • Add live discussion notes for comments discussed in Veeva Vault
  • Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize
  • and file approved minutes

  • Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
  • Cascade and enforce any new policies and guidelines related to review of materials.
  • Verifies that materials are assigned to the appropriate review path
  • Rejects incomplete submissions and materials that are not review ready
  • Facilitates/documents discussion in live meetings.
  • QCs Final Document vs. Approved Document
  • Supports FDA 2253 submissions with MLR Regulatory Reviewer/Partner
  • MEDICAL CONTENT SUPPORT RESPONSIBILITIES

  • Support the development of project plans
  • Support medical content development team
  • Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc.
  • MEDICAL AFFAIRS AND MEDICAL INFORMATION PROJECT MANAGEMENT SUPPORT

  • Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
  • All other duties as assigned.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    Qualifications

  • Education (i.e., degree required): Graduates in any Life Sciences / Biomedical field.
  • Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
  • Experience and/or Training :
  • At least 2 years of experience in a healthcare agency or pharmaceutical company
  • Experience with use of Veeva Vault PromoMats / MedComms
  • Experience in Scientific Writing / Scientific Reviewing / MLR
  • Project management
  • Time management
  • Meeting management
  • Excellent customer service skills.
  • Technology/Equipment : Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).
  • Work Perks

  • Competitive Wages

    Above market salary structures as part of our total rewards program

  • Retirement Resources

    Generous employer matching retirement solutions

  • Health & Wellness

    Leading health, dental and vision insurance products

  • Continuous Education

    Employer-funded tuition reimbursement

  • Global Workplace Flexibility

    Remote and hybrid work across the globe

  • Paid Time Off

    Generous paid time off including company holidays

  • Training & Development

    Company provided training and development

  • Employee Assistant Programs

    Offering financial, work-life balance, legal solutions and more to employees at no cost 24-7-365

  • This advertiser has chosen not to accept applicants from your region.

    Manager, Medical Data review

    Bengaluru, Karnataka IQVIA India

    Posted 4 days ago

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    Job Description

    Job Title : Mgr. Medical Data Review

    Location : Bangalore

    Years of Experience: 5+ Years.

    Job Location: Bangalore (Hybrid)

    Educational qualification: MBBS/MD is a must.


    Job Overview

    Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise.


    Essential Functions

    1. Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
    2. Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
    3. Define data capture requirements in line with protocol and reporting needs.
    4. Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
    5. Maintain strong customer relationships
    6. With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
    7. Ensure timely follow-up and resolution of compliance issues
    8. Serve as Subject Matter Expert (SME)
    9. Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
    10. Provide therapeutic area/indication training for the project clinical team.
    11. Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
    12. Manage staff in accordance with organization’s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.


    Qualifications

    1. MBBS/MD is mandatory.
    2. Equivalent combination of education, training and experience in lieu of degree Req
    3. Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
    4. Good understanding of clinical/medical data
    5. Proven expertise in the proactive identification of issues
    6. Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
    7. Proven ability to work within a matrix team environment requiring minimum level of supervision
    8. Attention to detail
    9. Interpersonal and analytical skills,
    10. Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
    11. Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
    12. Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve
    13. Excellent communication, interpersonal, customer service, and teamwork skills • Excellent organizational and problem-solving skills
    14. Excellent project management skills and coaching skills
    15. Ability to work with minimal supervision, using available resources
    16. Ability to work on multiple projects and manage competing priorities
    17. Strong customer focus skills
    18. Ability to establish and maintain effective working relationships with coworkers, managers and clients
    This advertiser has chosen not to accept applicants from your region.

    Manager, Medical Data review

    Bengaluru, Karnataka IQVIA India

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Job Title : Mgr. Medical Data Review

    Location : Bangalore

    Years of Experience: 5+ Years.

    Job Location: Bangalore (Hybrid)

    Educational qualification: MBBS/MD is a must.

    Job Overview

    Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise.

    Essential Functions

    • Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
    • Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
    • Define data capture requirements in line with protocol and reporting needs.
    • Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
    • Maintain strong customer relationships
    • With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Ensure timely follow-up and resolution of compliance issues
    • Serve as Subject Matter Expert (SME)
    • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
    • Provide therapeutic area/indication training for the project clinical team.
    • Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
    • Manage staff in accordance with organization’s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

    Qualifications

    • MBBS/MD is mandatory.
    • Equivalent combination of education, training and experience in lieu of degree Req
    • Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
    • Good understanding of clinical/medical data
    • Proven expertise in the proactive identification of issues
    • Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
    • Proven ability to work within a matrix team environment requiring minimum level of supervision
    • Attention to detail
    • Interpersonal and analytical skills,
    • Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
    • Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
    • Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve
    • Excellent communication, interpersonal, customer service, and teamwork skills • Excellent organizational and problem-solving skills
    • Excellent project management skills and coaching skills
    • Ability to work with minimal supervision, using available resources
    • Ability to work on multiple projects and manage competing priorities
    • Strong customer focus skills
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients
    This advertiser has chosen not to accept applicants from your region.
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    Manager, Medical Data review

    Bengaluru, Karnataka IQVIA India

    Posted 4 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    Job Title : Mgr. Medical Data Review
    Location : Bangalore
    Years of Experience: 5+ Years.
    Job Location: Bangalore (Hybrid)
    Educational qualification: MBBS/MD is a must.

    Job Overview
    Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise.

    Essential Functions
    Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
    Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
    Define data capture requirements in line with protocol and reporting needs.
    Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
    Maintain strong customer relationships
    With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
    Ensure timely follow-up and resolution of compliance issues
    Serve as Subject Matter Expert (SME)
    Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
    Provide therapeutic area/indication training for the project clinical team.
    Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
    Manage staff in accordance with organization’s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

    Qualifications
    MBBS/MD is mandatory.
    Equivalent combination of education, training and experience in lieu of degree Req
    Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
    Good understanding of clinical/medical data
    Proven expertise in the proactive identification of issues
    Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
    Proven ability to work within a matrix team environment requiring minimum level of supervision
    Attention to detail
    Interpersonal and analytical skills,
    Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
    Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
    Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve
    Excellent communication, interpersonal, customer service, and teamwork skills • Excellent organizational and problem-solving skills
    Excellent project management skills and coaching skills
    Ability to work with minimal supervision, using available resources
    Ability to work on multiple projects and manage competing priorities
    Strong customer focus skills
    Ability to establish and maintain effective working relationships with coworkers, managers and clients
    This advertiser has chosen not to accept applicants from your region.

    Manager, Medical Data review

    Bengaluru, Karnataka IQVIA India

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Job Title : Mgr. Medical Data Review

    Location : Bangalore

    Years of Experience: 5+ Years.

    Job Location: Bangalore (Hybrid)

    Educational qualification: MBBS/MD is a must.


    Job Overview

    Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise.


    Essential Functions

    1. Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
    2. Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
    3. Define data capture requirements in line with protocol and reporting needs.
    4. Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
    5. Maintain strong customer relationships
    6. With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
    7. Ensure timely follow-up and resolution of compliance issues
    8. Serve as Subject Matter Expert (SME)
    9. Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
    10. Provide therapeutic area/indication training for the project clinical team.
    11. Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
    12. Manage staff in accordance with organization’s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.


    Qualifications

    1. MBBS/MD is mandatory.
    2. Equivalent combination of education, training and experience in lieu of degree Req
    3. Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
    4. Good understanding of clinical/medical data
    5. Proven expertise in the proactive identification of issues
    6. Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
    7. Proven ability to work within a matrix team environment requiring minimum level of supervision
    8. Attention to detail
    9. Interpersonal and analytical skills,
    10. Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
    11. Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
    12. Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve
    13. Excellent communication, interpersonal, customer service, and teamwork skills • Excellent organizational and problem-solving skills
    14. Excellent project management skills and coaching skills
    15. Ability to work with minimal supervision, using available resources
    16. Ability to work on multiple projects and manage competing priorities
    17. Strong customer focus skills
    18. Ability to establish and maintain effective working relationships with coworkers, managers and clients
    This advertiser has chosen not to accept applicants from your region.
     

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