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The Sr. Scientist Drug Safety will perform in line medical safety review of individual case safety reports (ICSRs) reports and other AE reports of interest:
1. As required per SOP and in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead performs adverse experience reports review from specified sources in the safety database for regulatory reporting purposes
3. Develop working knowledge of pharmacovilance and regulatory reporting of ICSRs
5. May perform medical review of other reports of adverse events as required in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead
6. May perform ICSR follow up activities in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead
7. May participate in process, quality, innovation, technology and other business-related activities under the guidance of ICMR Physician/Management
8. May participate on special projects or rotational assignments within or outside of ICMR
The ICMR Associate with oversight from the ICMR Physician/Management and/or Therapeutic Area Team lead, may work closely and collaboratively with colleagues in other departments in the Company, including but not limited to: Global and US Pharmacovigilance, Global Pharmacovigilance Case Management, and Clinical Safety & Risk Management.
**Education**:
- Advanced/Graduate degree in nursing (e.g., MSN, CRNP), PharmD, Physician’s Assistant, M.D./D.O. or equivalent degree in Medicine, other relevant clinical health related field (undergraduate training is flexible) with an advance degree in a clinical discipline.
**Required Experience and Skills**:
- At least two years of clinical, pharmaceutical industry or related experience
- Clinically relevant medical experience
- Excellent writing and communication skills in English
- Effective presentation skills and experience influencing and negotiating
- Problem solving, conflict resolution and critical thinking skills
**Preferred Experience and Skills**:
- Experience in drug safety, pharmacovigilance and/or risk management is highly desirable
- Prior medical review and/or case management experience
- Relevant Safety Systems Experience
- Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
03/20/2025
**Requisition ID**:R338515
