Associate Director, Drug Safety

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage outsourced pharmacovigilance activities and assist in regulatory and safety deliverables.

• Collaborate with Quality, Clinical Operations, and Clinical Development to set up and implement safety processes.

• Provide daily oversight of both internal and external Serious Adverse Event (SAE) processing.

• Coordinate the reconciliation of safety information across clinical databases and with business partners.

• Monitor vendor performance by analyzing compliance trends and reviewing operational deliverables.

• Track action items, issues, and corrective measures.

• Assist in the implementation, maintenance, and enhancement of safety databases.

• Contribute to the preparation of aggregate safety reports and the safety sections of clinical, safety, and regulatory documents.

• Coordinate the safety data deliverables for aggregate reports, regulatory submissions, and requests from health authorities.

• Review individual and aggregate safety data to identify emerging trends.

• Co-author and maintain controlled documents, including Safety Management Plans, Safety Data Exchange Agreements, and other documents necessary for inspection readiness.

• Support Corrective and Preventive Actions (CAPAs), change controls, audits, and regulatory inspections.

• Carry out responsibilities throughout all phases of development for oral small-molecule oncology therapies.

• Report to the Head of Safety.

⛳️ Requirements

• A Bachelor's degree in nursing or pharmacy is mandatory.

• An advanced degree such as PharmD, MSN, MPH, or an equivalent qualification is preferred.

• A minimum of 10 years of combined experience in pharmacovigilance, drug safety, clinical science, or a related field with a bachelor's degree.

• 6 to 8 years of relevant experience with an advanced degree.

• Preferred experience in both safety science/surveillance and pharmacovigilance operations.

• Strong knowledge of MedDRA and WHODrug dictionaries is essential.

• Proficiency in using safety databases is required.

• Excellent interpersonal skills and a high level of professionalism.

• Strong written and verbal communication skills, with the ability to convey clinical topics clearly and concisely.

• Capability to train and mentor junior Drug Safety staff, contractors, consultants, and vendor personnel.

• Familiarity with applicable global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH, GCP, and GVP requirements.

• Experience in oncology phases I to III is preferred.

• Must be legally authorized to work in the United States.

• Must indicate whether visa sponsorship is currently or may be required in the future.

🏝️ Benefits

• Company-paid healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401(k) matching.

• Uncapped vacation.

• Onsite gym.

• Dining available at the facility.

• Flexible remote work arrangement or the option to work from the San Diego headquarters.