We currently have a position open for a Director of Pharmacovigilance responsible for the oversight of VIVUS’ contracted case processing function.
The Director of Pharmacovigilance would lead the global pharmacovigilance and drug safety group and activities. Responsibilities include assessing and managing the workload and resources of our Pharmacovigilance Contractor on an ongoing basis to maintain quality and high regulatory compliance. The candidate would manage compliance with standard operating procedures and Food and Drug Administration and World Health Organization global regulations for the reporting of adverse events to regulatory agencies. Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports.
- Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Oversees the development and preparation of reports for company management as well as external regulatory agencies.
- Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, and product labeling/package inserts and other reports as necessary.
- Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety.
- Effectively interfaces with all relevant internal departments, and healthcare customers.
Manages drug safety issues and crisis management on such issues, including participating in interactions with regulatory authorities around the world as needed.
- Serves as a key functional interface, in case of drug safety regulatory inspections and audits, together with Regulatory Affairs and Quality Assurance, in the management of such audits and any corrective action plans.
Requires a MD with a minimum 3 recent years of current Pharmacovigilance experience.
7 years within the pharmaceutical industry. Including experience in a management role and managing external contractors. Strong sense of ownership and commitment to excellence. Understanding of how pharmacovigilance impacts other aspects of Risk Management.
Knowledge of FDA regulations, knowledge of safety databases;
Broad knowledge of domestic and international drug safety regulations, industry practices, systems, and standards
Ensures compliance with all Company policies and procedures, including safety rules, and all applicable FDA, EMEA, and international regulations and guidance.
- Pharmaceutical and pharmacovigilance principles, practices and their application.
- Pharmacology principles, theory and their application.
- Food and Drug Administration (FDA), EMEA, ICH, GCP guidelines 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
Excellent written and oral communication skills, resourcefulness and personal organization skills
- Analyzing problems, identifying alternative solutions, project consequences of proposed actions and implementing recommendations that support department goals and objectives
- Proficient in Microsoft Outlook, Word, Power Point, and Excel
- Proficient in Databases