Pharmacovigilance Specialist
Company: Augmented
- Location: Indianapolis, United States
- Seniority: Entry level
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
We are seeking a Pharmacovigilance (PV) Specialist to support the monitoring, assessment, and reporting of adverse events and safety data associated with pharmaceutical or animal health products. This role ensures compliance with global regulatory requirements for drug safety surveillance and contributes to the ongoing evaluation of product safety profiles.
Key Responsibilities
- Receive, process, and evaluate adverse event (AE) reports from various sources (clinical trials, spontaneous reports, literature, regulatory authorities)
- Perform case intake, triage, data entry, and quality review of individual case safety reports (ICSRs) in the safety database
- Assess causality, seriousness, and expectedness of adverse events in accordance with regulatory guidelines
- Prepare and submit regulatory safety reports (e.g., expedited reports, periodic safety update reports (PSURs/PBRERs), DSURs) within required timelines
- Conduct literature surveillance and signal detection activities to identify potential safety concerns
- Support the maintenance and updates of safety documents (e.g., Company Core Data Sheets, Risk Management Plans)
- Ensure compliance with global PV regulations (FDA, EMA, ICH, and other applicable health authority requirements)
- Collaborate with regulatory affairs, clinical, medical, and quality teams on safety-related matters
- Support PV audits and inspections, ensuring documentation and processes are inspection-ready
- Maintain and update standard operating procedures (SOPs) related to pharmacovigilance activities
- Track and trend adverse event data to support ongoing benefit-risk assessments
Required Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field (or equivalent experience); advanced degree a plus
- Experience in pharmacovigilance, drug safety, or a related clinical/regulatory function
- Working knowledge of global PV regulations and guidelines (FDA, EMA, ICH E2 series)
- Experience with safety database systems (e.g., Argus, ArisGlobal, VigiFlow, or similar)
- Strong attention to detail and ability to manage time-sensitive regulatory reporting deadlines
- Strong written and verbal communication skills
- Ability to interpret and apply complex regulatory requirements
Preferred Qualifications
- Certification in pharmacovigilance or drug safety (e.g., Certified in Pharmacovigilance/Drug Safety)
- Experience with signal detection and risk management activities
- Familiarity with MedDRA coding and WHO Drug dictionaries
- Experience supporting regulatory inspections or audits
- Prior experience in animal health, pharmaceutical, or biotech industries
- Experience working in a global, cross-functional PV organization
Core Competencies
- Strong understanding of drug/product safety principles and regulatory compliance
- Analytical mindset for evaluating and interpreting adverse event data
- Cross-functional collaboration with regulatory, clinical, and quality teams
- High attention to detail and accuracy under deadline pressure
- Clear, precise written and verbal communication, including with regulatory authorities
