Associate Director, Pharmacovigilance

📋 Description

• Collaborate closely with the Safety team to assist in the execution of ongoing clinical trials.

• Guarantee patient safety and ensure adherence to regulatory standards throughout the drug development process.

• Oversee safety data management and play a key role in safety oversight.

• Evaluate adverse events, identify safety signals, and facilitate/contribute to SRC and DSMB meetings.

• Work in partnership with the pharmacovigilance team and various cross-functional teams.

⛳️ Requirements

• Educational background: PharmD or RN degree is mandatory.

• Experience in pharmacovigilance or clinical development within the biotech or pharmaceutical sector.

• Demonstrated experience in reviewing adverse events and collaborating closely with safety physicians.

• Practical experience in supporting DSMBs and SRCs, as well as preparing safety deliverables.

• Proficient in Microsoft Office Suite and Microsoft Teams, with the capability to utilize these tools for effective communication, scheduling, and documentation.

• Strong understanding of global PV regulations (FDA, EMA, ICH guidelines).

• Exceptional analytical, organizational, and communication abilities.

• Capacity to excel in a fast-paced start-up environment while managing multiple priorities.

• Proficiency with the Argus safety database.

• Familiarity with rare disease or oncology programs.

• Previous experience in a start-up or small biotech environment.

🏝️ Benefits

• Remote work opportunity available within the United States.