Pharmacovigilance Associate

This role will work closely with pharmacovigilance service providers, internal pharmacovigilance teams, and business partners to ensure accurate and timely pharmacovigilance information processing. Review of individual case safety reports (ICSR) ensuring that adverse event reports are processed in a timely manner, in accordance with the appropriate company SOPs, study protocols, and within regulatory timelines. End-to-end case processing for ICSRs from company sponsored trials including generating and raising queries to investigator sites. Assisting with pharmacovigilance processes, supporting preparation of SOPs, compiling data for FDA aggregate report submission

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 HR@insightglobal.com.

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

2-5 years experience in PV
Generic and branded pharma expeirence
Case processing experience
RPh, PHarmaD, RN degree
Experience authoring or reviewing FDA aggreagte safety reports
MedDRA exp

Clincal Trial activity support
ARGUS, ARISg Exp

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.