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    Serm Associate Scientific Director

    Gsk Plc
    7+ years
    Not Disclosed
    Bangalore
    10 Oct. 16, 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

    Job Description: SERM Principal Scientist

    Location: Bengaluru Luxor North Tower
    Posted Date: October 14, 2024

    Key Responsibilities:

    1. Scientific/Medical Knowledge & PV Expertise

      • Lead signal detection and evaluation activities for assigned products.
      • Ensure the provision of accurate evaluation documents with clear conclusions in response to internal or regulatory authority safety data requests.
      • Assist in the development of Risk Management Plans (RMPs) and Risk Tables, in consultation with senior personnel.
      • Author global regulatory periodic reports and associated documentation, adhering to agreed processes and timelines.
      • Participate in process improvement initiatives within the Global Clinical Safety & Pharmacovigilance (GCSP).
      • Complete post-audit and inspection activities within the required timelines.
      • Utilize various sources and methods to gather information, identify issues, propose solutions, and consult with SERM physicians for decision-making.
      • Demonstrate commitment to tasks with effective time management to meet multiple deadlines while maintaining attention to detail and quality.

    2. Cross-Functional Matrix Team Leadership

      • Build effective relationships and respond to line functions regarding safety issues.
      • Support safety governance and Safety Review Teams (SRTs) by establishing and operating cross-functional teams to address product safety issues, ensuring risk-reduction strategies are implemented in clinical protocols and labeling.
      • Mentor junior SERM colleagues, evaluating their activities and sharing knowledge and skills to support their development.

    3. Communications and Influencing

      • Share process improvement ideas with line managers and adapt behaviors based on changing environments.
      • Navigate ambiguity effectively, maintaining resilience and focus under pressure.
      • Demonstrate strong oral and written communication skills, articulating ideas clearly and incorporating feedback into deliverables.
      • Prepare detailed evaluations and reports, keeping managers informed of progress and escalating issues as necessary.
      • Effectively present and advocate for your viewpoints.

    Education Requirements:

    • Health Sciences/Healthcare Professional degree (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). An advanced degree is preferred.

    Job Related Experience Requirements:

    • 10-13 years of relevant experience in pharmacovigilance or drug development.
    • Experience in safety evaluation and risk management within clinical development and post-marketing activities.
    • Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development processes.
    • Proven experience working in large matrix organizations.

    Scope of Accountability:

    • Responsible for safety signal detection, assessment, and risk management, with the potential to chair Safety Review Teams.
    • Provide medical and scientific knowledge for safety evaluation and risk management of GSK products in clinical and post-marketing settings.

    Why GSK?
    GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease. Our focus is on developing vaccines and innovative medicines in key therapeutic areas, including infectious diseases, HIV, respiratory/immunology, and oncology.

    We aim to create an environment where individuals can thrive, feel valued, and grow. If you share our ambition to positively impact health on a global scale, join us on this exciting journey.

    Important Notice:
    GSK does not accept referrals from employment businesses or agencies without prior written authorization. Any unsolicited job advertisements or emails asking for payments for recruitment are fraudulent and not connected to GSK. For verification of job authenticity, please contact us at askus@gsk.com.

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