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

Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Veeva Safety preferred) Direct message the job poster from Syneos Health Overview 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. 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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong. Job Responsibilities General Develops and maintains Job Aids and process documents and maintains 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 may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will also be considered. Nothing herein should be construed to create an employment contract. The Company complies with applicable laws including the Americans with Disabilities Act and EU Equality Directive, as applicable. Summary Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Vault Safety preferred) Seniority level Entry level Employment type Full-time Job function Management and Manufacturing Referrals increase your chances of interviewing at Syneos Health by 2x Get notified about new Safety Specialist jobs in Buenos Aires, Argentina. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr