- Develop and maintain a repository for all relevant documents (Training, Safety and Pharmacovigilance Project Finance, Proposals tracking, etc.).
- Create and maintain Job Aids and process documents with necessary supporting documentation.
- Stay updated on FDA/EU/ICH guidelines and regulations regarding safety and PV reporting.
- Collaborate with operational SPVG team members and Therapeutic BU PMs to facilitate accurate and timely revenue recognition.
- Provide SPVG metrics as required.
- Perform other related duties as assigned.
- Minimal travel may be required (up to 15%).
Technology Responsibilities:
- Configure, administer, and maintain the Argus Safety database for project-specific requirements.
- Participate in audits and system demonstrations.
- Involve in the implementation and validation of Safety Systems projects, including testing and documentation.
- Assist in developing and maintaining departmental SOPs and WIs related to Safety Systems.
- Analyze programs for regulatory and customer report needs from Safety Systems.
- Enhance departmental efficiencies in Safety and Pharmacovigilance processes.
- Develop, validate, and maintain Safety reporting tools.
- Create and maintain Argus Project Information, User Access, and Report Request forms.
- Troubleshoot issues related to Argus and other Safety systems.
- Develop training materials for end users and train junior Safety Application Specialists.
- Assist with data migrations and custom reports.
- Generate quality-checked listings and reports from the safety database for internal and regulatory use.
- Represent the Safety Applications team at project and client meetings.
- Maintain expertise in Safety & PV systems through ongoing education and professional development.
Qualifications
Required Skills and Experience:
- Bachelor s degree in life science, nursing, pharmacy, computer science, or a related field, or equivalent experience.
- Experience with Safety Database systems and familiarity with medical terminology.
- Extensive clinical research experience or related work in the pharmaceutical or CRO industry.
- Proficiency in relational databases, with preferred experience in Oracle Insight/Analytics/Data Mart and SQL.
- Knowledge of ICH guidelines and regulations concerning safety and pharmacovigilance.
- Proficient in Microsoft Office Suite and email applications.
- Ability to work independently and as part of a team.
- Strong organizational and documentation skills, with a detail-oriented approach.
- Excellent communication and presentation skills.
- Capable of managing multiple priorities and making effective decisions.
