Pharmacovigilance Specialist

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 databaseAssess causality, seriousness, and expectedness of adverse events in accordance with regulatory guidelinesPrepare and submit regulatory safety reports (e.g., expedited reports, periodic safety update reports (PSURs/PBRERs), DSURs) within required timelinesConduct literature surveillance and signal detection activities to identify potential safety concernsSupport 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 mattersSupport PV audits and inspections, ensuring documentation and processes are inspection-readyMaintain and update standard operating procedures (SOPs) related to pharmacovigilance activitiesTrack 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 plusExperience in pharmacovigilance, drug safety, or a related clinical/regulatory functionWorking 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 deadlinesStrong written and verbal communication skillsAbility 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 activitiesFamiliarity with MedDRA coding and WHO Drug dictionariesExperience supporting regulatory inspections or auditsPrior experience in animal health, pharmaceutical, or biotech industriesExperience working in a global, cross-functional PV organization Core Competencies Strong understanding of drug/product safety principles and regulatory complianceAnalytical mindset for evaluating and interpreting adverse event dataCross-functional collaboration with regulatory, clinical, and quality teamsHigh attention to detail and accuracy under deadline pressureClear, precise written and verbal communication, including with regulatory authorities