Medical Safety Specialist

2 days ago

Hyderabad, Telangana, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 20,00,000
Job Opportunity

At our organization, we empower biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs by providing expert advice and support throughout the product lifecycle.

We partner with clients through a collaborative model that combines deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology.

The Role:

The Pharmacovigilance Specialist, Case Processing is responsible for managing individual case safety reports, performing initial case-level assessment, confirming seriousness, composing medical narratives, and generating queries for missing information.

The Specialist ensures cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines and applicable safety regulations.

Key Responsibilities:
  • Process adverse event cases (clinical trial and/or post-marketed) including coding using MedDRA, determining seriousness and expectedness at the event and case level.
  • Perform case follow-up activities such as identification of information to be collected during follow-up.
  • Creating and reviewing case narratives.
  • Providing client notifications as required for case management.
  • Supporting training materials and delivery.
  • Highlighting areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing.

Maintain up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed.

Necessary Skills And Abilities:
  • Strong verbal, written and interpersonal communication skills.
  • High level of accuracy and attention to detail.
  • Ability to identify and resolve problems in a timely manner.
  • Able to work independently and collaboratively in a multi-disciplinary team.
  • Excellent organization and prioritization skills; able to multitask.

Bachelor's degree in life sciences is required, advanced degree or equivalent preferred. Basic knowledge of Pharmacovigilance is essential for success in this role.

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