Ora is the world’s leading full-service ophthalmic drug and device development firm, dedicated to advancing eye care through innovative clinical research. With over 45 years of expertise, Ora has played a pivotal role in earning more than 85 new product approvals, helping bring life-changing therapies to market. Our integrated clinical data solutions, global regulatory strategies, and cutting-edge methodologies have been proven across thousands of projects worldwide.
Headquartered in the United States, Ora has a global footprint with over 600 employees across North America, Europe, Asia, and Latin America. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology, improving how we see and heal the world.
At Ora, we prioritize kindness, operational excellence, cultivating joy, and scientific rigor. We are committed to creating an inclusive, supportive, and diverse workplace where every team member can thrive.
Job Description: Safety Specialist
Ora is seeking a highly motivated and experienced Safety Specialist to join our Medical Safety team in Hyderabad, Telangana. This role is critical to ensuring the safety and efficacy of ophthalmic clinical trials by managing safety documentation, tracking adverse events, and supporting global safety reporting.
Key Responsibilities:
- Safety Documentation: Create and maintain Safety Management Plans (SMPs) and Medical Monitoring Plans (MMPs) tailored to client needs.
- Adverse Event Management: Perform quality checks on Serious Adverse Events (SAEs), track SAEs through completion, and liaise with Data Management to resolve safety queries.
- Safety Reporting: Prepare Patient Profiles for Data Safety Monitoring Board (DSMB) meetings and assist with SAE/AESI/UADE/Pregnancy Report reconciliation.
- Database Management: Serve as a superuser for the Global Safety Database, ensuring accurate and timely data entry and reporting.
- Regulatory Compliance: Maintain safety and medical monitoring plans in the Trial Master File (TMF) and ensure adherence to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) guidelines.
- Literature Review: Conduct literature searches to support aggregate and expedited safety reporting.
- Collaboration: Work closely with Medical Monitors, Data Management, and Safety Physicians to ensure the highest standards of safety in clinical trials.
- KPIs and Metrics: Support the tracking of Key Performance Indicators (KPIs) to measure and improve safety processes.
Qualifications:
- Education: BS in Nursing, Pharmacy, or a related Life Science field with healthcare experience.
- Experience:
- Minimum 3 years of drug and/or device safety experience.
- Minimum 3 years of clinical research experience (Sponsor or CRO-level).
- Minimum 2 years of experience with Safety Database systems (e.g., Argus Oracle, AB Cube SafetyEasy, Veeva Safety).
- Minimum 2 years of global safety management and submission experience (e.g., Eudravigilance).
- Skills:
- Proficient in MS Office (Word, Excel, PowerPoint).
- Strong knowledge of GCP and GVP guidelines.
- Excellent communication, organizational, and problem-solving skills.
- Personal Traits:
- Execution excellence with a focus on delivering high-quality work.
- Agile, collaborative, and empathetic team player.
- Strong commitment to ethical practices and patient safety.
Why Join Ora?
At Ora, we believe in creating a meaningful impact on global eye health while fostering a supportive and inclusive work environment. Here’s what we offer:
- Well-Being: Comprehensive healthcare options (Medical, Dental, and Vision) starting day 1.
- Work-Life Balance: Flexible PTO, unlimited sick time, and 14 company-paid holidays.
- Financial Security: Competitive salaries and a 401K plan with company match.
- Family Support: Adoption and fertility assistance, plus 16 weeks of paid parental leave.
- Remote & Wellness Support: Reimbursement for remote workspace setup and wellness purchases.
- Career Growth: Opportunities for professional development and global collaboration.
- Impact: Contribute to groundbreaking research that improves vision and quality of life for patients worldwide.
