Safety Specialist

POSITION TITLE: SAFETY SPECIALIST                                                                                                            

DEPARTMENT: MEDICAL SAFETY

Ora values the daily practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Safety Specialist (SS) is an important member of the Medical Safety team. Reporting to the Medical Safety Director, the SS is responsible for the preparation of Safety Management Plans, Medical Monitoring Plans, Patient Profiles, and Safety reports for all clinical trials managed by Ora Safety. The SS tracks requests for Safety study documents and updates each study team on Safety deliverables and helps to maintain Safety plans in each study’s Trial Master File. The SS performs quality checks on submitted Serious Adverse Events and liaises with Data Management to issue safety queries. The SS serves as a superuser for the Global Safety Database.

What You’ll Do:

• Create and maintain safety management plans according to Client needs.
• Create and maintain medical monitoring plans with oversight from the assigned Medical Monitor.
• Performs quality checks on clinical safety database.
• Tracks SAEs through completion and assists the Safety Physician/Medical Monitor to issue safety queries.
• Reviews Safety Narratives for Medical Monitor input needed.
• Assist with SAE/AESI/UADE/Pregnancy Report reconciliation with Data Management and Safety Vendor.
• Prepares Patient Profiles on assigned studies for review during Clinical Data Review Meetings or for Data Safety. Monitoring Board meetings.
• Performs literature search to support aggregate reporting or expedited reporting.
• Performs an analysis of similar events (AOSE) in the safety database.
• Provide safety review of other clinical study documents as assigned by the Medical Safety Director.
• Maintains Safety and Medical Monitoring Plans in the respective Project Trial Master File.
• Serves as Safety Database superuser.
• Willing to adhere to flexible work hours to support expedited Safety reporting.
• Support tracking of Key Performance Indicators on an ongoing basis as assigned by the Medical Safety Director.
• Attend Department Meetings.
• Support other Department needs as assigned by the Chief Medical Officer.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • BS Nursing, Pharmacy, or Other Life Science degree with healthcare experience, and
  • Minimum 3 years’ Drug and/or Device Safety experience, and
  • Minimum 3 years’ clinical research experience (Sponsor or CRO-level);
  • Minimum 2 years’ experience with Safety Database systems (e.g. Argus Oracle; AB Cube SafetyEasy, Veeva Safety);
  • Minimum 2 years’Global safety management and submission experience (e.g. Eudravigilance).

• Additional Skills and Attributes:
  • Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)
  • MS Office expert.

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.  
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match. 
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. 
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. 
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. 
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. 
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.  
• Global Team: Opportunities to work with colleagues across the globe. 
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. 

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. 

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. 

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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