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    Senior Drug Safety Associate

    Eversana
    5+ years
    Not Disclosed
    Pune
    10 Dec. 12, 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

    Company Overview:

    At EVERSANA, we are honored to be recognized globally as a Great Place to Work. Our mission is to create a healthier world through the power of innovation. Our global team of more than 7,000 employees is dedicated to delivering next-generation commercialization services to the life sciences industry. We serve over 650 clients, from innovative biotech startups to established pharmaceutical companies. Together, we bring innovative therapies to market and support the patients who depend on them.

    We embrace diversity in backgrounds and experiences, recognizing that improving patient lives around the world requires people from all walks of life. EVERSANA fosters an inclusive culture where every team member’s unique skills and perspectives thrive. Together, we shape the future of healthcare and life sciences, driven by our shared commitment to making a difference for our clients, colleagues, and the patients we serve.

    Position: Pharmacovigilance (PV) Associate
    Location: [Insert Location]
    Job Type: Full-time

    Job Description:

    As a Pharmacovigilance (PV) Associate, you will be a critical team member in the processing and analysis of safety data from clinical trials and spontaneous post-marketing reports. This position involves both teamwork and independent contributions to ensure regulatory compliance and timely reporting of adverse events (AEs).

    Essential Duties and Responsibilities:

    • Work closely with PV Management and/or assigned Project Manager to meet client project deadlines.
    • Provide support to other PV Associate staff to manage workload and ensure timely reporting to Regulatory Authorities.
    • Participate in the development of EVERSANA-PV and client documents (e.g., aggregate reports, standard operating procedures).
    • Collect adverse events (AEs) from various sources, track cases through processing activities, and ensure accurate and timely reporting.
    • Independently assess the reportability, seriousness, expectedness, and causality of AEs in compliance with regulatory guidelines.
    • Code adverse events using MedDRA and medications to WHODRUG.
    • Perform Quality Control checks for completeness and accuracy in the safety database and regulatory reporting forms (e.g., MedWatch, CIOMS I).
    • Independently draft narratives for AEs based on reporter descriptions, applying standard guidelines and grammar rules.
    • Formulate follow-up queries as needed for clarification.
    • Ensure compliance with timelines for expedited case report submissions.
    • Assist in the compilation of aggregate reports and other regulatory documents as requested.
    • Interact with clients and stakeholders for safety data collection and reconciliation.
    • Lead or support team members in case processing activities, ensuring efficient workflows.
    • Reconcile serious adverse events (SAEs) between drug safety and clinical trial databases with minimal supervision.
    • Develop expertise in client products within assigned therapeutic areas.
    • Ensure adherence to relevant corporate and global regulations, SOPs, and writing practices.

    Minimum Knowledge, Skills, and Abilities:

    • BS degree in a life science discipline (e.g., pharmacy, nursing) preferred.
    • 5 years of relevant experience, including 3 years in drug safety.
    • Broad knowledge of domestic and international drug safety regulations and industry standards.
    • Strong attention to detail, teamwork, and initiative.
    • Familiarity with MedDRA and WHODRUG coding dictionaries.
    • Knowledge of FDA and international adverse event reporting regulations (ICH guidelines).
    • Solid understanding of medical terminology and principles of adverse event reporting.
    • Proficiency in using safety databases and Microsoft Office Suite.
    • Ability to follow established processes while adapting to new practices and priorities.
    • Good planning and organizational skills.

    Additional Qualities:

    • Positive Attitude & Energy: Demonstrates enthusiasm and motivates others.
    • Communication Skills: Effectively articulates ideas and encourages team collaboration.
    • Innovative Thinking: Develops creative solutions to improve company performance.
    • Highly Principled: Upholds integrity and ethical standards in all actions.

    Compensation and Benefits:

    EVERSANA offers competitive salaries and benefits. Compensation will be determined based on relevant experience and qualifications.

    Diversity, Equity & Inclusion:

    At EVERSANA, Diversity, Equity, and Inclusion are central to our success. We are an Equal Opportunity Employer, embracing people with diverse strengths, experiences, and backgrounds. Diversity includes race, gender identity, age, disability status, veteran status, sexual orientation, religion, and more. We believe that all viewpoints are critical to our success, and inclusion is everyone's responsibility.

    Fraud Prevention:

    Be aware of fraudulent job offers impersonating EVERSANA. We never request personal information or payments during recruitment. If you receive such offers, please report them immediately.

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