Literature Review and Safety Reporting Specialist

3 days ago


Ahmedabad, Gujarat, India beBeeSpecialist Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Specialist, PV

As a subject matter expert within the Safety Operations Literature team, this position serves as a key player in individual case safety reporting and scientific literature review.

Key Responsibilities:

  • Supervise quality of abstract review, article review, and individual cases processed by outsource vendors through random QC or aggregate data review.
  • Provide training to outsource vendors for Literature review and case processing, including new hire onboarding and ongoing feedback.
  • Process literature adverse event reports as part of a cross-functional team.
  • Interface and collaborate with functional partners at various organizations to facilitate global exchange of safety information.
  • Participate in compliance supervising related activities, including CAPA and Quality Control Metrics.

Required Skills and Qualifications:

  • Bachelor's or Master's degree in Pharmacy.
  • Minimum 2 years patient care experience or equivalent AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (e.g., ARISg, Argus).
  • Knowledge of multiple therapeutic areas equivalent position.
  • Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department.
  • Excellent analytical & problem-solving skills.
  • Excellent oral and written communication.
  • Collaborative interpersonal skills to cultivate a team environment.
  • Ability to work independently under deadlines and changing priorities.
  • Able to multitask and prioritize changing workload every day.
  • In-depth knowledge of worldwide and regional safety regulations.


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