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    Pharmacovigilance Associate

    Dr Reddy's
    3-4 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 team of over 24,000 employees is united by a collective purpose: 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 focused on 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: Associate, Pharmacovigilance Team
    Location: Hyderabad
    Reports to: Head of Pharmacovigilance and Medical Affairs - North America

    Primary Responsibilities:

    • Draft procedural documents including Standard Operating Procedures, Work Instructions, and Guidance Documents to capture PV processes.
    • Participate in the review, formatting, and routing of procedural documents authored by other team members.
    • Assist in the development of training materials for procedural documents to test and document understanding.
    • Support the development of training curricula for the global PV team and affiliates.
    • Develop and deliver adverse event reporting training for non-PV internal teams and drug safety vendors.
    • Perform and compile requests for information (RFI) with PV data, adverse event collection, case processing, signal and risk management, clinical studies, PV safety concerns, etc.
    • Handle PADERS submission and publishing for all DRL products and acquired products.
    • Manage regulatory correspondences by updating the PV shared drive and sending labeling updates to other PV stakeholders.
    • Ensure the provision of strategic information and complete PV due diligence for potential product acquisitions/divestitures.
    • Maintain the North America Product List for PV oversight including Master list, external, and in-licensing products.

    Secondary Responsibilities:

    • Triage adverse events received from other manufacturers and forward them promptly for case processing.
    • Ensure compliance with executed Pharmacovigilance Safety Data Exchange Agreements (SDEA) and routine reconciliations.
    • Support the finance team in collating and processing multiple invoices from safety and risk management program vendors.
    • Maintain document security and integrity by filing PV documents in a secure room or sending indexed files to offshore archival.
    • Prioritize multiple projects with minimal assistance, suggest solutions to complex issues, and deliver complete and accurate information within deadlines.
    • Support North America and Global PV teams with audits/inspection readiness.
    • Perform duties in accordance with Dr. Reddy’s business principles, corporate directives, SOPs, and government and industry guidelines.
    • Perform other relevant tasks as requested by management.

    Qualifications

    Educational Qualification:

    • Bachelor's degree in Pharmacy

    Work Experience:

    • 3-4 years of drug safety experience in the pharmaceutical industry with knowledge of global pharmacovigilance regulations

    Technical Skills:

    • Working knowledge of ICH-GCP guidelines and global PV regulations, including FDA, Health Canada, and EU
    • Experience in drafting SOPs and Work Instructions and preparing training materials
    • Proficient in MS Office: Word, Excel, PowerPoint

    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:
    Dr. Reddy’s offers industry-leading benefits 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:
    At Dr. Reddy’s, 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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