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    Medical Safety Lead

    Novartis
    12+ years
    Not Disclosed
    Barcelona Hyderabad
    10 Oct. 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Summary
    In close collaboration with the Global Program Safety Lead (GPSL), this role provides essential safety evaluation expertise and medical innovation to enhance patient outcomes and positively impact Novartis results. As a member of the Medical Safety organization, the individual will prioritize patient safety, ensuring optimal safety for assigned compounds while integrating, analyzing, and evaluating internal and external safety information throughout the product lifecycle.

    About the Role
    Note: This position is available in Hyderabad, India, and Barcelona, Spain.

    Job Description

    Major Accountabilities:

    • Monitor the clinical safety of projects/products through literature reviews, individual case evaluations, signal detection, and responding appropriately to safety-related inquiries.
    • Conduct medical assessments and related activities for cases, including gathering follow-up information, evaluating product quality defects associated with adverse events, reviewing single case line listings, and preparing notifications for investigators and periodic medical assessments for ethics committees.
    • Identify safety signals from the review of both solicited and unsolicited single cases.
    • Perform signal detection, monitoring, and evaluation of all safety signals.
    • Provide inputs for inquiries from regulatory authorities or healthcare professionals regarding safety issues.
    • Prepare safety data for Health Authority review boards.
    • Contribute to responses for legal queries and requests from Country Organizations involving safety issues.
    • Offer expert evaluations on the clinical context of adverse event reports and their implications for Novartis products.
    • Collaborate effectively with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments on clinical safety tasks.
    • Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, reports, and investigator brochures. Participate in Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed, and support licensing activities, regulatory inspections, and project/product recall activities.

    Minimum Requirements:

    • A Bachelor’s degree in Pharmacy, Nursing, PharmD, PhD in a relevant field, or a Medical Degree (MBBS or MD) is required; a specialization is preferred. A medical degree is essential for associates performing medical reviews of single case reports as needed.
    • Relevant experience (e.g., clinical, postdoctoral) after graduation.
    • A minimum of 12 years in drug development within a major pharmaceutical company, including at least 6 years in patient safety in an operational or medical role (or equivalent experience) is desirable.
    • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and preparation of publications.
    • Proven ability to analyze, interpret, discuss, and present safety information effectively, both in writing and verbally.
    • Experience in preparing or contributing to clinical safety assessments and regulatory reports involving safety information.
    • Experience in issue management related to safety or other concerns.

    Join Our Novartis Network:
    If this role doesn’t align with your experience or career goals, but you wish to stay connected with Novartis and learn about future opportunities, consider joining the Novartis Network: Join the Novartis Network.

    Why Novartis:
    At Novartis, we believe that helping people with diseases requires more than just innovative science; it takes a community of passionate individuals who support and inspire one another. Together, we can achieve breakthroughs that transform patients' lives. Ready to create a brighter future together? Learn more about our culture.

    Benefits and Rewards:
    Explore the various ways we support your personal and professional growth in our benefits handbook: Read our Benefits and Rewards.

    Division: Development
    Business Unit: Innovative Medicines
    Location: India
    Site: Hyderabad (Office)
    Company / Legal Entity: Novartis Healthcare Private Limited (IN10)
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Accessibility and Accommodation:
    Novartis is dedicated to providing reasonable accommodations for individuals with disabilities. If you require assistance during the recruitment process or need accommodations to perform essential job functions, please email diversityandincl.india@novartis.com with details of your request and your contact information, including the job requisition number.

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