Deputy Director, Safety

Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs.  We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve.   We are EVERSANA.  

Job Description

THE POSITION:

The purpose of this role is to ensure all levels of the team understand how to identify and report safety, and the implications to the patient, client, and EVERSANA when reporting is done correctly and incorrectly; comply with the SDEA.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

• Oversee and ensure the timely and compliant execution of the Safety Data Exchange Agreement (SDEA) audit requirements.
• Communicate actionable insights from the SDEA audit results.

• Establish and maintain a partnership with client stakeholders and understand and execute client’s safety priorities.
• Provide strategic quality oversight activities to safety and promote operational and compliance excellence, quality risk management and knowledge management.
• Report and escalate any significant compliance risks and issues to client.
• Coach staff to support safety subject matter expertise building and talent development through onboarding and mentoring.

• Maintain expertise in safety and promote increased awareness among team.
• Accountable for all strategic safety activities for client.
• Maintain awareness and ensure adherence to established safety SOP’s.
• Ensure safety reporting business continuity.
• Support internal and external PV audits and inspections.
• Act as the responsible contact person for safety-related initiatives of the client program.
• Ensure internal safety processes and procedures are well documented and support compliant regulatory/PV activities.
• Set clear direction, effective plans, and measurable outcomes.
• Ensure work is accomplished effectively by managing employee performance, work processes and other resources.
• Plan, organize, and coordinate all safety-related projects.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. 
• All other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EXPECTIONS OF THE JOB:

• Deep knowledge of, and practical experience in identifying and reporting product safety information.
• Ability to interpret safety reporting trends; develop strategies and tactics to respond to trends.
• Ability to comply with client defined safety reporting standards and Safety Data Exchange Agreement.
• Respond promptly to customer needs and proactively solicit client feedback to improve safety and reduce risk.
• Adapt to a fast paced, dynamic environment, make independent decisions, maintain confidential information and meet deliverables.
• Travel 10-25%.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, know