Careers

Director, Drug Safety & Pharmacovigilance

ArriVent is a clinical-stage biopharmaceutical company with employees across the US and sites in Gaithersburg MD and Burlingame CA.  We are dedicated to the identification, development and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors.

Reporting to the VP of Drug Safety and Pharmacovigilance (DSP), the Director of DSP has overall responsibility for drug safety activities for the assigned products as well as contributing to furthering the development and implementation of the clinical safety strategy. The incumbent will assume the safety lead role for overseeing safety and pharmacovigilance for the assigned products (early stage and late-stage assets) in clinical development and expected global registrational filings and launches of the assigned late-stage product. The incumbent must possess a strong knowledge of global pharmacovigilance regulations and best industry practices to effectively manage and solve PV challenges, as well as hands on experience in medical review of adverse event information and implementation of safety signal detection and risk management strategies.

Essential Responsibilities

• Create and maintain a signal detection plan and process, perform regular and ad hoc reviews of aggregate safety data, and present the safety analysis/summary in the Company Safety Governance Committee or clinical team meetings for the assigned products.
• Serve as SME author and/or reviewer for drug safety related regulatory reports (including Drug Safety Update Report (DSUR), 6-monthly SUSAR reports, PSUR) and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety, product package labeling, Company Core Safety Information, Risk Management Plan, etc).
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data. Conduct ad hoc safety analysis for emerging safety signals or per requests from health authorities.
• Represent DSP in supporting global market application/filing activities and iDMC (independent Data Safety Monitoring Committee)/Data Review Committee activities.
• Represent DSP in communication with regulatory authorities/IRBs/study sites/external investors and lead/review responses to safety-relate queries.
• Conduct real-time medical review of ICSRs (individual case safety reports) inclusive of case narratives and causality assessments of SAEs and AEs of special interest (AESI) collected from all sources of clinical studies and literature publications worldwide.
• Determine processes and/or tools supporting Pharmacovigilance signal management in accordance with PV regulations.

Required Education and Experience

• Doctor of Medicine (or X-US equivalent) or PharmD with industry experience in oncology clinical development required.
• 10 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety monitoring in clinical development/post-marketing. At least 5 or more years in the area of drug safety science with strong background in signal detection, risk management and safety data analysis. A mix of large and small company experience preferred.
• In depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation.
• Experience with NDA/MAA filing and pre- and post-launch global PV activities highly preferred.
• Excellent scientific and analytical knowledge base, with ability to assess data and understand the safety and medical implications.
• Expert knowledge of the regulations governing pharmacovigilance.
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.