Pharmacovigilance Analyst

• Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document

• Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA codding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.

• Accountable to perform Literature Review as per the applicable organization’s SOP and WI

• Accountable preparation and/or review of aggregate reports as per applicable SOP and WI including but not limited to Annual Summary Reports (ASR), Issue Related Summary Report (IRSR), Periodic Safety Update Reports (PSURs), Periodic Benefit- Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADER), Developmental Safety Update Report (DSUR), etc.

• Accountable for performing Signal Detection as per applicable SOP and WI Accountable for preparation and/or update of Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents

• Accountable to act as a contact point for the client Work directly with internal and external stakeholders to request additional information or clarification as necessary;

• Assist in audit preparation File and store all documents as per applicable SOP and WI.

• Other tasks assigned by the Manager, as needed. May be required to be on standby / on-call as part of this role.

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.