Merck Bangalore Hiring ICSR Safety Physician- MBBS/MD degree for Pharmacovigilance Role

Merck Bangalore Hiring ICSR Safety Physician- MBBS/MD degree for Pharmacovigilance Role

19 February, 2022

TITLE: Safety Physician, Expert

Role: E2

PURPOSE OF THE ROLE

  • To perform the medical assessment of individual case safety reports (ICSR) in company’s safety database system. Work in close collaboration with the involved stakeholder to ensure that each case is assessed in a proper way to ensure patients safety.
  • Work with the vendor performing the case management and/or medical assessment of ICSR on behalf of company to ensure the medical quality of the ICSR.
  • Interface with medical safety teams on active pharmacovigilance activities on products in clinical development and post-marketing.

KEY TASKS & RESPONSIBILITIES

    • Medical review and approval of ICSR clinical trial cases by performing a thorough medical evaluation of serious and non-serious cases, authoring and/or reviewing the PV comment
    • Contribution to quality KPI compilation while assessing the quality of medical assessment of cases reviewed and approved by vendors
    • Ensure timely completion of the task by daily monitoring of workflows and ensuring compliance
    • Ensure close interaction with Medical Safety if an “Index-case” was identified
    • Ensure issuing of proper medical queries to obtain follow-up information for the ICSR
    • Provide operational expertise in case processing activities
    • Contribute to regulatory inspections and audits and support the development of CAPA plans as needed
    • Maintenance of reference tools and documents relevant to medical review activities
    • Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.

EDUCATION & LANGUAGES

    • Physician with MBBS/MD degree including relevant clinical experience

PROFESSIONAL SKILLS & EXPERIENCE

    • Minimum 3 years of professional experience/experience in the pharmaceutical or biotech industry with at least 2 years in patient safety/pharmacovigilance
    • Minimum of 2 years working in hospital or private praxis prior to joining the pharmaceutical industry
    • Expert knowledge of international regulatory safety reporting requirements, including EMA/FDA/ICH guidance’s related to pharmacovigilance (e.g. E2B) and Good Pharmacovigilance Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
    • Expert in Medical Coding (e.g. MedDRA)
    • Good understanding of drug development and life-cycle management

PERSONAL SKILLS & COMPETENCIES

    • Ability to work in intense, fast paced, matrixed, multinational work environment
    • Strong communication skills (oral, written and listening)
    • Ability to effectively communicate with employees, colleagues, and global counterparts
    • Positive motivator through demonstration
    • Strong intercultural skills (developed from practical experience)
    • Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’
    • Good problem-solving and decision-making ability
    • Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities
    • Ability to manage multiple situations/issues under time pressure
    • Effective presentation and training skills
    • Ability to present and critically discuss safety data in both internal and external discussions
    • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
    • Team player with ability to function in a cross-functional environment
    • Self–motivated, able to prioritize and plan effectively, and independently, with minimal supervision
    • Ability to navigate in databases and pull information correctly
    • Good organizational skills and attention to detail

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID:  237699

Location:  Bangalore

Career Level:  C – Professional (1-3 years)

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