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    Pv Specialist - It And Digitalization

    Dr Reddy's
    2-6 years
    Not Disclosed
    Hyderabad
    10 June 27, 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, 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

    Company Description

    Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a global presence. Our 24,000+ employees work every day to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

    • Founded: 1984
    • Employees: 24,000+
    • Global Presence: Research and development centers, manufacturing facilities, or a commercial presence in 66 countries

    For nearly four decades, we have emphasized access, affordability, and innovation, supported by deep scientific knowledge, progressive people practices, and robust corporate governance. As the pharmaceutical industry evolves, we aim to strengthen our core and build the future through our strategy, 'The Next and the New.' Our goal is to reach over 1.5 billion patients worldwide by 2030, prioritizing sustainability in our operations.

    Commitment to Diversity:
    Dr. Reddy’s maintains a work environment free from discrimination and is an equal opportunity employer. We are committed to employing and nurturing a diverse workforce without regard to race, color, religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship, or any other protected characteristic.

    Job Description

    Position: PV Specialist – IT and Digitalization
    Location: Hyderabad
    Reports to: Head of PV Operations

    Primary Responsibilities:

    • Serve as the PV Subject Matter Expert for the global safety database and associated systems.
    • Act as the primary liaison for internal DRL IT in support of safety database maintenance and changes.
    • Coordinate with the vendor supplier of the safety database and associated systems.
    • Provide system administration support for central safety database applications.
    • Coordinate, implement, and provide training for PV system projects and follow through the full project lifecycle.
    • Develop user requirements, functional specifications, and propose solutions for unmet safety system business needs.
    • Analyze, collect, test, implement, and maintain safety database configuration changes.
    • Perform quality control checks on configuration changes and resolve discrepancies.
    • Support testing and validation processes for pharmacovigilance IT projects, including generating appropriate documentation.
    • Develop and provide complex specialized data outputs from the safety database for various Pharmacovigilance reports and ad hoc queries.
    • Ensure understanding of pharmacovigilance requirements and processes to support process improvement initiatives and regulatory changes.
    • Provide training to new team members on the PV system.
    • Provide safety database SME support during audits and Regulatory Authority Inspections.

    Relationship Management:

    • Build relationships with key stakeholders (internal and external, including the Global Pharmacovigilance Team, DPEX, and the safety database vendor).
    • Define practices under the supervision of the Head of PV Operations and support their implementation.

    Process Improvement / Standardization:

    • Assess existing processes against external benchmarks and industry best practices.
    • Identify areas for improvement and propose recommendations in functional reviews.
    • Develop and implement action plans for approved changes.

    Qualifications

    Educational Qualification:

    • B. Pharm, M. Pharm, or Life Science Post Graduate

    Experience:

    • Ideally 6+ years in the Pharma industry in either pharmacovigilance data entry or Pharma IT role, with at least 2+ years in safety database management.

    Technical Skills:

    • Working knowledge of ICH-GCP guidelines and global PV regulations, including FDA, Health Canada, and EU.
    • Experience with the LifeSphere Safety Database (formerly ARISg), both from a user and technical interface perspective.
    • Experience retrieving data from relational databases.
    • Programming skills.
    • Experience with IT projects, GXP, and validation requirements.
    • Knowledge of MedDRA dictionary handling and LSMV Drug Dictionary Management System.

    Behavioral Skills:

    • Excellent communication skills for liaising with external PV vendors and internal teams (i.e., RA, QA).
    • Ability to make decisions based on FDA, HC, ICH-GCP, and GPVP standards.
    • Strong documentation skills.

    Additional Information

    Benefits Offered:
    At Dr. Reddy’s, we actively support your career growth and professional development through personalized learning programs. The benefits you will enjoy are on par with the best industry standards, including joining and relocation support, family support (maternity and paternity benefits), learning and development opportunities, medical coverage for you and your family, and life coverage.

    Our Work Culture:
    Our guiding principle is "Good Health Can’t Wait." We view healthcare solutions as a means to help patients lead healthier lives. Our culture of empathy and dynamism supports individual abilities while fostering teamwork and shared success. We believe in the power of diverse skills bound by a common purpose and value system.

    For more details, please visit our career website: Dr. Reddy’s Careers

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