Jobs in La Jolla

About The Position

Requirements

• Bachelor’s degree in a life sciences discipline required; PharmD, MD, PhD, RN, or MSc preferred.
• Minimum of 10 years of biopharmaceutical industry experience, including at least 7 years in pharmacovigilance with increasing levels of responsibility.
• Strong knowledge of global PV regulations, ICH GCP, ICH and GVP Modules.
• Demonstrated experience leading pharmacovigilance operations and vendors, including case processing oversight and global safety reporting.
• Proficiency with safety databases (e.g., Argus), MedDRA/WHODrug coding, and electronic safety submissions.
• Experience contributing to or leading safety activities across multiple phases of clinical development.
• Strong communication and leadership skills, with proven ability to influence and manage in a matrix environment.
• Track record of audit and inspection readiness, including SME participation.
• Strategic thinker with attention to detail, accountability, and a drive for operational excellence.
• Ability to thrive in a fast-paced, evolving biotech environment, adapting quickly to shifting priorities.

Responsibilities

• Serve as Global Patient Safety Operations Lead across multiple clinical programs, ensuring operational excellence in PV activities from study start-up through closeout.
• Lead and oversee all case processing and safety reporting activities, ensuring compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA, EudraVigilance) and internal SOPs.
• Provide strategic oversight and management of CROs/vendors, including budget ownership, KPI development and monitoring, and performance reviews.
• Develop and maintain study-specific Safety Management Plans (SMPs), ensuring alignment with protocols, data collection tools (eCRFs), and reconciliation procedures (SAE, AESI, pregnancies).
• Ensure timely and accurate ICSR submission, case reconciliation, and global safety exchange with partners and regulatory agencies.
• Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements.
• Lead day-to-day operations of the PV Vendor through performance of Quality Check (QC) activities related to ICSR processing, regulatory reporting, and follow-up.
• Oversee PV contributions to clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, DSURs, and CSRs.
• Support aggregate safety data reviews, signal detection activities, and cross-functional safety meetings.
• Drive development, review, and implementation of PV Standard Operating Procedures (SOPs), Work Instructions (WIs), and process improvement initiatives.
• Support PV readiness for health authority inspections and internal/external audits; act as subject matter expert during inspection-related activities.
• Provide PV training to internal and external stakeholders, including clinical teams, CROs, and investigators.
• Represent the PV function in cross-functional projects and contribute strategic safety input into corporate initiatives.
• Support safety database configuration and oversight, MedDRA/WHODrug updates, and system transitions as applicable.
• Mentor and support junior staff and lead PV operational sub-teams as required.

Benefits

• Full range of health benefits, including Medical, Dental & Vision, with options for 100% EMPLOYER PAID premiums for employee and family!
• Employee Stock Purchase Program (ESPP)
• Competitive salaries and bonus plans plus equity via Stock Options
• Free variety of snacks and beverages
• Health and Wellness programs
• $100 Anniversary cash awards with opportunity to increase to $2000!
• Referral Bonuses
• Company sponsored FUN events