Director, Drug Safety Operations

Proclinical is currently seeking a Director of Drug Safety Operations for a biopharmaceutical company located in South San Francisco, CA. Successful candidate will provide leadership and direction to the Drug Safety department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Cytokinetics clinical trials.

Job Responsibilities:

• Managing SAE/SUSAR reporting activities for all investigational drugs.
• Managing preparation and processing of internal and external SAE reports.
• Reviewing incoming adverse events to determine action required.
• Overseeing maintenance of a hosted electronic database for tracking, storing, and reporting serious adverse events from clinical trials.
• Ensuring corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs.
• Collaborating with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements.
• Leading preparation of safety-related plans with partners and CROs.
• Providing guidance and support to project teams for safety-related areas, including protocol development and study conduct
• Contributing to preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
• Assisting with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.
• Training staff and external CRO's on drug safety principles and procedures.
• Managing and mentoring staff and assign responsibilities as appropriate to meet timelines and quality metrics.
• Responding to safety-related queries from regulatory authorities or Ethics Committees.
• Collaborating to ensure alignment among case handling, aggregate reporting, and signal detection activities.

Skills and Requirements:

• MA/MS or PhD in life sciences, nursing, pharmacy, or medicine.
• 5+ years pharmaceutical industry drug safety experience.
• Knowledge of and experience with international regulatory adverse event reporting
• Hands-on experience with adverse event case processing.
• Proven experience and effectiveness at training and mentoring drug safety staff.
• Excellent knowledge of MedDRA coding and WHODrug coding.
• Ability to work independently, establish functional priorities and execute on goals.
• Excellent interpersonal communication skills and ability to work effectively as part of teams.
• Experience in neurology and/or cardiovascular drug development desirable.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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