Senior Director, Safety and Pharmacovigilance

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

📋 Description

• Oversee global Safety and Pharmacovigilance (PV) operations to guarantee adherence to relevant regulatory requirements and guidelines.

• Manage adverse event case processing (ICSRs) and aggregate reporting (DSUR) to ensure timely submission of high-quality safety reports to regulatory agencies and external stakeholders.

• Lead the preparation and review of safety-related sections within clinical and regulatory documents.

• Collaborate with Clinical Leads and Medical Monitors for medical review and documentation of individual adverse events and reactions, ensuring proper assessment of case seriousness, causality, expectedness, medical coding, and follow-up actions.

• Act as the primary point of contact with internal departments and external partners regarding Safety and PV matters.

• Create and update drug safety forms and templates, ensuring alignment with clinical operations during study initiation and execution of clinical studies.

• Oversee relationships with Safety and PV vendors, ensuring the execution of responsibilities and compliance with safety data processing and submission activities.

• Ensure effective reconciliation of serious adverse events (SAEs) between clinical and safety databases.

• Develop and implement enhancements to Safety and PV processes, tools, systems, and procedures.

• Contribute to responses for regulatory inquiries and safety concerns.

• Assist in the creation and updates of safety documents, including core data sheets, investigator brochures, labels, and Risk Management Plans (RMPs) as needed.

• Participate in regulatory inspections and internal audits, and draft responses to any findings.

• Maintain close interactions and oversee the evaluation and performance of assigned staff, fostering a culture of professional development.

• Capable of working collaboratively across various development and functional areas within the organization.

⛳️ Requirements

• At least 5 years of experience in Drug Safety and Pharmacovigilance within a biopharmaceutical or biotechnology company.

• A background as a healthcare professional (e.g., MD, RN, BSN, PharmD, Physician Assistant) is essential.

• Strong comprehension of global Safety and PV regulations, including EU and US regulations and ICH guidelines.

• Excellent knowledge of Good Pharmacovigilance Practices, Good Clinical Practice (GCP), clinical trial methodologies, and medical terminology.

• Proficient in safety databases (e.g., Argus), regulatory requirements, and MedDRA coding.

• Outstanding interpersonal, organizational, and communication abilities.

• Strong project management and problem-solving skills.

• Detail-oriented with a quality-focused mindset.

• Proven capability to prioritize tasks and meet deadlines.

• Demonstrated initiative and adaptability through effective and innovative leadership.

• Strong negotiation and communication skills, with the ability to work in a global, culturally diverse setting.

• Ability to perform effectively both independently and as part of a team.

• Willingness to travel as necessary.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD).

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a year-end holiday week.

• Recognition program, Bonus.ly.