Principal Safety Operations Specialist - Quality Focused

Syneos Health, Inc.; India; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Syneos Health, Inc. is seeking a Principal Safety Operations Specialist with a quality-focused mindset to strengthen safety governance across drug development programs. You will develop and maintain safety documentation, monitor SPVG metrics, and mentor teams in safety procedures.

You will ensure compliance with FDA/EU/ICH guidelines, oversee deliverables quality, and support audit readiness while collaborating with SPVG and Therapeutic BU PMs on revenue targets and process improvements.

Qualifications

• Develops and maintains Job Aids and process documents and keeps supporting documentation as needed.
• Maintains knowledge of applicable FDA/EU/ICH guidelines and PV reporting requirements.
• Provides mentoring and training on processing and reporting of safety procedures.
• Oversees activities to ensure quality and timely completion of deliverables.

Responsibilities

• Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
• Facilitates SPVG Annual Revenue targets by working with the SPVG team and BU PMs/Project Directors to ensure accurate recognition in RBB.
• Provides SPVG metrics at agreed intervals based on assigned tasks.
• Provides mentoring and training on processing and reporting of safety procedures.
• Maintains knowledge of FDA/EU/ICH guidelines and PV reporting requirements.
• Oversees quality and timely completion of deliverables.
• Performs other duties as assigned.

Job description

Principal Safety Operations Specialist - Quality Focused

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
• Facilitates SPVG Annual Revenue targets by working with the operational SPVG team members and Therapeutic BU PMs / Project Directors, to ensure accurate and timely recognition of the BU in RBB.
• Responsible for providing SPVG metrics as appropriate at agreed upon intervals based on assigned tasks.
• Provides mentoring and training on processing and reporting of safety procedures.
• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
• Provides oversight of activities and the quality and timely completion of deliverables.
• Performs other work-related duties as assigned.

Quality & Compliance

• Responsible for Quality Planning activities by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents; tracks and communicates quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.
• Responsible for Quality Assurance activities by identifying and communicating areas of risk through risk-based process assessments;
• Responsible for Quality Compliance verification and performance of quality control activities.
• Provides expertise for procedures and QI support. May liaise with management and internal Corporate Quality Assurance (CQA) to monitor and ultimately bring to resolution any open QIs.
• Supports the safety project teams in maintaining audit and inspection readiness.
• Responsible for Quality Improvement activities including the developing and promoting improvement initiatives; identifies and communicates deficiencies and/or deviations from company, department, or client processes; manages, tracks and/or assists with corrective and preventive action development and completion; participates in root cause analysis process.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legisla