Job Details

Job Title: Drug Safety Consultant II Location: 100% Remote Duration: 6-Month Contract (Potential for Extension or Conversion) Pay Rate: $89.99 $110.76/hour (W2) Benefits: Weekly pay; Medical, Dental, and Vision coverage Role Overview The PV Scientist serves as the product lead for Pharmacovigilance (PV) activities within the Safety function. This role is responsible for overseeing day-to-day safety operations for clinical trials related to assigned product(s), leading or supporting safety signal management, and contributing to aggregate reporting activities (e.g., PSURs, DSURs, Line Listings) and Risk Management Plans (RMPs). The PV Scientist acts as a Subject Matter Expert (SME), providing guidance to cross-functional teams on global safety regulations, data analysis, and product-specific safety information. The role also involves responding to safety-related inquiries from internal and external stakeholders and reviewing medical and scientific literature for relevant safety insights. Key Responsibilities Lead and/or support the signal management process, including signal detection, tracking, evaluation, and documentation for assigned product(s) Analyze and synthesize safety data from multiple sources and author signal evaluation reports Facilitate Safety Signaling Team meetings and contribute to decision-making on safety risks Conduct and manage literature reviews to identify relevant safety information Respond to safety-related queries from regulatory authorities in collaboration with cross-functional teams Manage aggregate safety reports, including strategy, review, and finalization of documents such as PSURs, DSURs, REMS, and RMPs Collaborate with Global Safety Officers and Safety MDs on clinical trial activities (e.g., protocol and ICF review), safety committees, and data analysis Oversee day-to-day safety operations and safety management plans for assigned clinical trials Support ad hoc safety analyses and product-related activities as required Qualifications & Required Skills Minimum of 7 years of Pharmacovigilance experience, including expertise in aggregate safety reporting and signal management Bachelors degree in a biological, natural science, or healthcare-related field required; advanced degree (PhD, MPH, NP, PharmD, etc.) preferred Strong knowledge of MedDRA terminology and its application Excellent analytical and problem-solving skills Advanced proficiency in Microsoft Office applications, particularly Excel Ability to thrive in a fast-paced environment with multiple competing priorities TMNaa415a4b-8b21-40fc-a65c-70d2b25ca29a