Pharmacovigilance Safety Systems

Job Description

Summary:

· This position facilitates the design, deployment and maintenance of safety databases and related pharmacovigilance systems.

Key Responsibilities:

· Provide strategic and operational support for the design and deployment of PV/Safety System including but not limited to Veeva Safety, Veeva SafetyDocs, Rave Safety Gateway and Commonwealth Vigilance Workbench

· Collaborate with IT, Vendors and PV team to ensure safety systems validation, upgrades, and data migration are compliant with regulatory and business requirements

· Provide business needs assessment and project management support for PV Safety Systems project and initiatives.

· Support with creation, and maintenance of Line Listings, reports for safety data analysis and signal detection

· Develop project and validation documentation for PV projects

· Perform User Acceptance Testing

· Perform system administrative updates, and user access management

Payrate - 95/hr

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Must Have:

· Minimum 8 years of experience working with Safety Databases/PV systems

· Minimum bachelor's degree in Life Sciences, Information Technology, Engineering or related field

· Proficiency in one or more PV Safety Databases (e.g., Oracle Argus or Veeva Safety) implementations, data migration and operations

· Experience in implementing gateways between PV Safety Database and other databases

· Excellent analytical, problem-solving and organizational skills

· Strong systems-thinking, strategic planning and project management skills

· Excellent oral and written communication skills Ability to actively contribute to continual process improvement initiatives within GPV

· Ability to build relationships and influence across disciplines and all levels

· Working knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA, and ICH guidelines

· Exhibits attributes congruent with Sarepta Behaviors: Patients First, Action, Unconventional Thinking, Talent, and Integrity

· Global experience is preferred