Safety & PV Ops Specialist II – Technology Support, ARGUS Console, Veeva Safety
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇦🇷 Argentina
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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.
- 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.
Requirements
- 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
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
safety database managementmedical terminologyperformance qualification (PQ) scriptsdata migrationmetrics generationproject-specific configurationscompliance reportingsafety data analysisregulatory compliancedocumentation maintenance
Soft skills
communication skillspresentation skillsinterpersonal skillsorganizational skillsdetail orienteddecision makingability to prioritizeteamworkindependent worktime management
Certifications
Bachelor's degree in life scienceBachelor's degree in nursingBachelor's degree in pharmacyBachelor's degree in computer scienceequivalent combination of education and experience