Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Veeva Safety preferred)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong. 

Job Responsibilities

General

• Develops and maintains Job Aids and process documents andmaintains supporting documentation for these documents as needed.

• Ensures compliance to Standard Operating Procedures (SOP), Policies and SMP documents

• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.

• Supports annual revenue targets by working with the operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB.

• Provides metrics as appropriate at agreed upon intervals based on assigned tasks.

• Performs other work-related duties as assigned.

Technology

• Assist with the management and maintenance of the safety database, including but not limited to:  User set-up and maintenance  Project-specific configurations  Routine safety database patches and updates  Routine MedDRA and WHO drug dictionary updates  Performance qualification (PQ) scripts for safety database updates/changes  Maintenance of systems to ensure compliance with reporting requirements

• Assist with the management and maintenance of other SPVG applications (e.g. SharePoint).

• Provide project support related to safety database issues and data outputs for Safety & PvG projects utilising the Syneos Health safety database.

• Assist with the execution and validation of safety data migrations into the safety database.

• Generate listings, reports and queries from the safety database for internal, client, or regulatory use

• Participate in project meetings as requested.

• Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards.

• Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops

• Assist with other SPVG initiatives as needed.

Qualifications

• Bachelor's degree in life science, registered nurse, pharmacist, computer science or other technology related field (technical role) ,or equivalent combination of education and experience.

• Safety Database systems and moderate medical terminology required

• Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.

• Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.

• Ability to work independently and in a team environment

• Ability to successfully prioritize and work on multiple tasks

• Excellent communication, presentation, interpersonal skills, both written and spoken

• Strong organizational and documentation skills

• Detail oriented with a high degree of accuracy and ability to meet deadlines

• Able to make effective decisions

• Manage multiple priorities

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.

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 legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.