Director, Global Pharmacovigilance

Director, Global Pharmacovigilance

POSITION SUMMARY:

This position will hold primary responsibility for the day-to-day activities of the Pharmacovigilance and Drug Safety Department. The individual will function as an interdepartmental project lead in the handling and analyses of safety data from clinical trials and spontaneous post-marketing reports. The individual will work closely with the VIVUS assigned project lead to facilitate and meet project deadlines. This will include such activities as oversight and management of vendors, ensuring timely reporting of SAEs to Regulatory Authorities, and cross-reporting to pharmaceutical partners. This position will also participate in development, implementation, and maintenance of quality systems for all global pharmacovigilance activities, encompassing processes, procedures, compliance, and metrics.

RESPONSIBILITIES:

The major duties and responsibilities will include but are not limited to the following:

• Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners, etc.
• Participate in the preparation of aggregate safety reports such as Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), quarterly safety reports to Ethics Committees, and annual reports to regulatory authorities.
• Process SAE and AE reports of marketed and investigational products in accordance with all applicable regulations, guidelines including Safety Management Plans, and SOPs with little or no supervision. This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.
• Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies.
• Conduct quarterly safety signal review and analyses for all portfolio products.
• Liaise with commercial partners’ pharmacovigilance departments to coordinate maintenance of related global safety databases.
• Maintain a high level of understanding of federal and international regulations and guidance in order to guide departmental policies and procedures.
• Evaluate project case workflow and offer solutions for process improvement.
• Ensures compliance with all Company policies and procedures, including safety rules, and all applicable FDA, EMEA, and international regulations and guidance. Manages department needs as it relates to identifying changes in FDA regulations or guidances and assessing the potential impact on the Drug Safety Department's functions and resources.

REQUIREMENTS:

Minimum Bachelor's degree required. MD strongly preferred with a minimum of 10 years of relevant experience in the pharmaceutical industry.

Broad knowledge of domestic and international drug safety regulations, industry practices, systems, and standards, including:

• Pharmaceutical and pharmacovigilance principles, practices, and their application.
• Pharmacology principles, theory, and their application.
• Food and Drug Administration (FDA), EMEA, and other international regulations and guidance.
• Working knowledge with at least one major safety database system (e.g., Argus, ARIS-g, Oracle AERS, E-Trace).
• Medical terminology and treatment modalities.
• Working knowledge of MedDRA and WHODRUG coding dictionaries.

Strong attention to detail, teamwork, and initiative:

• Analyzing problems, identifying alternative solutions, project consequences of proposed actions and implementing recommendations that support department goals and objectives.

Excellent written and oral communication skills, resourcefulness, and personal organization skills:

• Proficient in Microsoft Outlook, Word, Power Point, and Excel
• Proficient in Databases