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Drug Safety Associate

Location: Hyderabad, India

Company: Azurity Pharmaceuticals

About Us: Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to creating innovative products that address the needs of underserved patients. As a leader in providing unique, accessible, and high-quality medications, we leverage our integrated capabilities and extensive partner network to continuously expand our commercial product portfolio and robust late-stage pipeline. Our patient-centric products serve various markets, including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan diseases, benefiting millions of patients. For more information, visit www.azurity.com.

Position Summary: The Medical Affairs Group at Azurity Pharmaceuticals is seeking a highly motivated Drug Safety Associate to join our team in Hyderabad. Reporting to the Director of Drug Safety, this individual will support Pharmacovigilance activities across the organization. The ideal candidate will possess existing industry knowledge, organizational skills, and strong communication abilities to support ongoing drug safety initiatives while maintaining compliance.

Responsibilities:

  • Assist in maintaining compliance with Pharmacovigilance (PV) activities per company policies, SOPs, and FDA regulations.
  • Assist in editing, renewing, and tracking safety agreements.
  • Manage and oversee safety-related information.
  • Review and manage individual case reports, including those from company-sponsored clinical trials.
  • Manage the core drug safety email system.
  • Track and manage reconciliations between partners.
  • Coordinate daily workflows and cross-functional communications to ensure timely partner responses.
  • Review, oversee, and organize weekly and monthly safety reports.
  • Organize safety project management internal tools.
  • Review, organize, and author standard operating procedures.
  • Maintain electronic files to ensure audit readiness.
  • Review Expedited and Non-expedited safety reports and source documents for completeness and accuracy.
  • Contribute adverse event information for safety reports, including PADERs, PSURs, and clinical reports.
  • Maintain pertinent workflows to improve the quality and submission of reports.
  • Prepare and edit safety-related training materials.
  • Collaborate with other departments to ensure timely processing of reports.
  • Maintain the integrity of confidential information throughout the work process.

Qualifications:

  • Bachelor’s or master’s degree in life sciences or a healthcare-related field, OR an equivalent combination of education and experience.
  • At least 3 years of experience reviewing individual case reports, aggregate reports, and literature for adverse event reporting.
  • Strong analytic skills to summarize case reports, studies, and specific topics.
  • Experience with literature databases.
  • Excellent communication and organizational skills.
  • Ability to work in a fast-paced environment.
  • Experience with safety databases.
  • Problem-solving skills, particularly in enforcing safety rules and global procedures.
  • Fluency in English with excellent written and oral communication skills.
  • Proactive behavior with the ability to meet timelines.
  • High degree of responsibility, accountability, and responsiveness.
  • Ability to develop cooperative working relationships at all staff levels.
  • Proficiency in medical terminology and MedDRA coding.
  • Competency with Adobe Acrobat and Microsoft Office (Word, Excel, PowerPoint).
  • Capable of working in a team-oriented and rapidly changing environment.
  • Working knowledge and understanding of FDA Regulations.

Physical & Mental Requirements:

  • Must be able to sit for long periods.
  • Frequently required to stand, walk, sit, talk, and hear.
  • Occasionally climb stairs and/or ride elevators.
  • Must occasionally lift and/or move up to 25 pounds.
  • Able to manipulate keyboard, operate a telephone, and hand-held devices.
  • Perform other miscellaneous job duties as required.

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