Drug Safety Associate – Pharmacovigilance
Location: Hyderabad, India
Company: Azurity Pharmaceuticals
About Us:
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company focused on creating innovative products for underserved patients. We offer unique, accessible, and high-quality medications across various markets, including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan diseases. For more information, visit www.azurity.com.
Position Summary:
We are seeking a highly motivated Drug Safety Associate to join our Medical Affairs Group in Hyderabad. Reporting to the Director of Drug Safety, the ideal candidate will support Pharmacovigilance activities and ensure compliance with company policies and FDA regulations.
Responsibilities:
- Assist in maintaining compliance with 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 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.
- 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 for audit readiness.
- Review Expedited and Non-expedited safety reports for completeness and accuracy.
- Contribute adverse event information for safety reports (PADERs, PSURs, clinical reports).
- Maintain workflows to improve report quality and submission.
- Prepare and edit safety-related training materials.
- Collaborate with other departments for timely report processing.
- Maintain the confidentiality of information throughout the work process.
Qualifications:
| Criteria | Requirements |
|---|---|
| Education | Bachelor’s or master’s degree in life sciences or healthcare-related field, or equivalent combination of education and experience. |
| Experience | Minimum 3 years in reviewing case reports, aggregate reports, and literature for adverse event reporting. |
| Skills | Strong analytic, communication, and organizational skills. Experience with safety databases and literature databases. Proficiency in medical terminology and MedDRA coding. Competency with Adobe Acrobat and Microsoft Office. |
| Abilities | Ability to work in a fast-paced environment, enforce safety rules, and develop cooperative working relationships. Proactive behavior, high responsibility, and responsiveness. Fluency in English. |
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.
Join us to contribute to our mission of delivering high-quality medications and improving patient care.