Pharmacovigilance Scientist

Role: Pharmacovigilance Scientist supporting drug safety monitoring during clinical development of biologics targeting chronic skin diseases, such as plaque psoriasis. Responsibilities encompass safety data collection, adverse event review, signal detection, risk assessment, and preparation of safety documentation (e.g., DSURs, RMPs). The role collaborates closely with cross-functional teams including clinical operations, regulatory affairs, and data management, and supports compliance with global pharmacovigilance regulations. Qualifications include an advanced life sciences degree (e.g., PharmD, PhD), at least 3 years of industry experience in drug safety, proficiency with safety databases (Argus, MedDRA, Veeva Vault), and knowledge of GxP and regulatory guidelines (FDA, EMA, ICH). The position involves working remotely or hybrid in Waltham, MA, with a 3-day in-office requirement, and may include some travel. The role offers a competitive salary range of $130,000 to $161,000, along with benefits, professional growth opportunities, and an inclusive startup culture focused on innovative biologics for dermatologic therapies.