Senior Expert in Global Pharmacovigilance

24 hours ago

Hyderabad Secunderabad Telangana, India beBeeLiterature Full time ₹ 5,00,000 - ₹ 8,00,000
Job Description

We are seeking a skilled Literature Review Specialist to join our team. The Literature Review Specialist will be responsible for conducting literature reviews to support global safety processes, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

The Literature Review Specialist will review weekly literature results imported into the literature citation management system to determine if they meet minimum criteria for Individual Case Safety Reports (ICSRs) for marketed products. They will also assess literature articles to identify new aggregate safety information relevant to periodic reports or signal detection activities.

Additional responsibilities include:

  • Ordering full-text articles when additional detail is required to determine reportability or support signal detection
  • Flagging relevant articles containing aggregate safety information for secondary review by Therapeutic Area (TA) Safety
  • Coordinating with Local Safety Officers to obtain English translations of non-English articles
  • Notifying business partners upon receipt of relevant literature articles, if applicable
  • Conducting retrospective quality checks of literature reviews performed by the team

Periodic Reporting Process

The Literature Review Specialist will also assist with quality control activities related to periodic safety reporting, as needed. This includes extracting citations from literature databases for inclusion in periodic aggregate safety reports.

Key Activities

The Literature Review Specialist will execute weekly literature reviews in support of global literature surveillance. They will also support audits and inspections by retrieving citations from the literature management system, and assist with quality control tasks to ensure high standards in periodic reporting.

Required Skills and Qualifications

To succeed in this role, the Literature Review Specialist should have:

  • Familiarity with assigned product profiles to assess reportability of literature content
  • Ability to identify articles with ICSR criteria or containing safety signals for escalation
  • Proficiency in full-text article retrieval and ordering procedures
  • Strong prioritization skills and ability to manage concurrent timelines
  • Demonstrated understanding of global pharmacovigilance regulations and surveillance standards
  • Expertise in literature citation management systems and configuring literature search strategies

Benefits

The successful candidate will contribute to Amgen's continued compliance with global regulatory requirements through high-quality literature reviews, and be responsible for timely completion of weekly literature screening to support global safety processes.

Educational Requirements

A Bachelor's degree in a relevant field, such as Life Sciences, Pharmacy, or related field, is required. Direct experience in bibliographic databases and literature review is preferred.

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