Safety Specialist

1 day ago

Hyderabad Secunderabad Telangana, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 28,00,000

As a Global Product Safety Specialist, you will be accountable for ensuring the quality of Individual Case Safety Reports (ICSRs) globally. This role involves significant vendor oversight, ensuring compliance with approved processes, and maintaining a state of inspection readiness.

Key Responsibilities
  • Quality Assurance & Vendor Oversight: You will be accountable for the quality of device and combination product ICSR processing for both clinical trial and post-market cases. This includes ensuring vendors deliver high-quality cases through metric management and comply with worldwide regulatory authority requirements. You'll also be responsible for raising case-related issues and providing vendors with necessary training and resources.
  • Regulatory Compliance & Reporting: Ensure compliance and timely reporting of device and combination product cases through the query process. This includes submitting all individual case safety reports to business partners and vendors. You'll also support audits and external inspections, including liaising with vendors as needed.
  • Process Implementation & Support: Contribute to the implementation of new intake-related systems, processes, and procedures. You will apply analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems.
  • Documentation & Standards: Work within the Quality Management System framework and implement Standard Operating Procedure requirements for device and combination product cases. You'll ensure the quality of PC, AE, and OSF records.
Qualifications
  • A Doctorate degree with 4 years, a Master's degree with 7 years, or a Bachelor's degree with 9 years of experience in Drug Safety or Life Sciences is required.
  • Experience in Pharmacovigilance or Quality within the biotech, pharmaceutical, or medical device industry is preferred.
  • A Bachelor's degree in a health-care subject area or scientific field is required.
  • An understanding of applicable global regulatory requirements, including Good Manufacturing Practices and Good Pharmacovigilance Practices.
  • Previous experience with a corporate intake system or safety database.
Skills
  • Analytical: The ability to apply analytical skills to evaluate moderately complex situations and develop solutions to technical problems.
  • Attention to Detail: A high level of attention to detail to ensure high case-level productivity and quality.
  • Communication: Strong communication skills to support interactions with business partners and vendors.
  • Time Management: The ability to successfully manage your workload to meet strict timelines and consistently deliver on-time, high-quality results.

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