Drug Safety Specialist

6 days ago

Pune, Maharashtra, India The HIRD Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Job Title:
Medical Reviewer / Medical Quality Reviewer

Location:
Pune | NCR | Kolkata

Working Model:
Hybrid

Qualifications:

  • MBBS (Medical Degree), preferably with a postgraduate qualification.
  • Minimum
    2+ years of experience
    in clinical practice or pharmacovigilance (PV).
  • Must hold valid
    Medical Doctor certification/licensure
    in the country of service.
  • Experience in the pharmaceutical industry preferred.
  • Working knowledge of
    international regulations and guidance documents
    related to worldwide reporting requirements (US/EU).

Key Responsibilities:

  • Perform comprehensive
    medical review
    of cases, ensuring consistency and accuracy of information.
  • Provide
    causality assessment
    and
    clinical evaluation comments
    as required.
  • Support the preparation of
    clinical trial safety assessments
    ,
    regulatory submissions
    , and
    aggregate safety reports
    .
  • Ensure compliance with
    pharmacovigilance regulations
    and company policies.
  • Identify and resolve issues independently; escalate complex matters appropriately.
  • Demonstrate strong
    analytical and decision-making skills
    in both routine and complex scenarios.
  • Collaborate effectively within a
    matrix organization
    , working both independently and under supervision.
  • Maintain high productivity, organization, and time management to meet regulatory compliance goals.
  • Exhibit
    excellent oral and written communication
    in English.

Skills & Competencies

  • Strong understanding of
    pharmacovigilance processes
    and
    safety data management
    .
  • Proficiency in
    database management systems
    and computer applications.
  • Excellent organizational and problem-solving skills.
  • Ability to work under tight timelines while maintaining quality standards.

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