Drug Safety Scientist

JOB DISCRIPTION Job Title: Drug Safety Scientist Functional Reporting: Associate Director, Safety & Pharmacovigilance 1 . JOB PURPOSE The Drug Safety Scientist supports pharmacovigilance activities across the product lifecycle, from clinical development through post-marketing surveillance. The role evaluates and interprets safety information to identify potential risks, support ongoing benefitrisk assessment, and promote patient safety. The position contributes to case safety assessment, safety surveillance, signal detection and evaluation, aggregate safety reporting, risk management, and regulatory safety activities, while collaborating with cross-functional stakeholders to ensure compliance with applicable global pharmacovigilance regulations, guidelines, and company procedures. 2. DUTIES AND RESPONSIBILITIES Adverse Event Management: Review, assess, code, and follow up on adverse event and serious adverse event reports from clinical trials, healthcare professionals, patients, literature, and post-marketing sources. Perform medical assessment, including causality and clinical significance, as applicable.Case Quality and Reporting: Ensure Individual Case Safety Reports (ICSRs) are complete, medically consistent, accurately documented, and processed or submitted within applicable regulatory timelines.Safety Signal Detection: Analyze safety databases, clinical data, literature, and other relevant sources to identify unexpected trends, emerging risks, changes in event frequency, or other potential safety concerns.Signal Evaluation and Risk Assessment: Conduct signal validation and assessment, evaluate causality and clinical relevance, and determine whether new safety information may impact the product safety profile or overall benefitrisk balance.Aggregate Safety Reporting: Prepare, review, and/or contribute to aggregate safety reports, including DSURs, PSURs/PBRERs, PADERs, benefitrisk assessments, and other regulatory safety documents, with analysis of cumulative safety data.Risk Management and Safety Surveillance: Support Risk Management Plans (RMPs), safety surveillance strategies, additional monitoring activities, risk-minimization measures, and safety-related labeling updates throughout the product lifecycle.Clinical Trial Safety Oversight: Provide safety input into clinical study protocols, Safety Management Plans, Investigators Brochures, informed-consent materials, SAE reconciliation, and clinical study reports, as applicable.Literature Surveillance: Review scientific and medical literature for reportable adverse events, emerging safety information, and potential safety signals relevant to assigned products.Regulatory and Health Authority Support: Respond to safety-related health authority queries and contribute to regulatory submissions, safety assessments, and other pharmacovigilance documentation.Safety Governance and Communication: Participate in safety governance meetings and present safety data, emerging risks, signal assessments, benefitrisk considerations, and recommendations to relevant stakeholders.Cross-Functional Collaboration: Work closely with Drug Safety/Pharmacovigilance Physicians, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Quality, Data Management, vendors, and global safety teams.Regulatory Compliance: Ensure pharmacovigilance activities are conducted in accordance with applicable FDA, EMA, MHRA, ICH, GVP, company SOPs, safety agreements, and other global regulatory requirements.Audits and Inspections: Support pharmacovigilance audits, regulatory inspections, and related follow-up or corrective actions as required. The scope of responsibilities may vary based on experience and seniority. At earlier career levels, the role may have greater emphasis on case review and operational safety activities, while more experienced scientists may assume increased responsibility for signal assessment, aggregate reporting, risk management, benefitrisk evaluation, and product-level safety strategy. 3. QUALIFICATIONS Education: Bachelors, Masters, PharmD, MD, PhD, RN, or equivalent degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related scientific discipline.Experience: Typically, 8+ years of relevant pharmacovigilance, drug safety, or clinical safety experience, depending on position level and seniority.Regulatory Knowledge: Strong understanding of ICH guidelines, Good Pharmacovigilance Practices (GVP), FDA and EMA requirements, and other applicable global safety regulations.Safety Terminology & Coding: Working knowledge of MedDRA and WHO Drug Dictionary/WHO Drug.Safety Systems: Experience with pharmacovigilance databases such as Oracle Argus Safety, Veeva Vault Safety, ARISg, PV-Works, or comparable systems.Core Skills: Strong analytical and critical-thinking skills, scientific writing capability, attention to detail, and effective written and verbal communication. 4 . PREFERRED SKILLS / TOOLS Experience with .