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Director/Senior Director, Pharmacovigilance

Portola Pharmaceuticals, Inc.

South San Francisco, CA
Posted Date:
Position Type:
Contract, Full time
Job Code:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Portola Pharmaceuticals Inc., is a biopharmaceutical company focused on the discovery and development of the novel therapeutics for the treatment and prevention of severe cardiovascular diseases. With one of the most experienced discovery and development teams in the areas of vascular thrombosis and inflammation, Portola is applying an integrated discovery and development approach to a comprehensive understanding of platelet physiology and vascular thrombosis, with an eye toward developing new therapeutics where current antithrombotic therapies are inadequate.

The Portola Clinical Development Department seeks a full time Director/Senior Director, Pharmacovigilance to establish and enhance safety data collection procedures, databases and routine safety review procedures to support Portola’s programs and activities. This position reports to the Senior Vice President, Clinical Development and is located in South San Francisco at Portola’s headquarters.

Responsibilities -
• Provide strategic planning, implementation and management of pharmacovigilance processes to support clinical development and ensure compliance with global PV regulations
• Provide expertise in pharmacovigilance methods, pharmacoepidemiology and applicable global drug safety regulations
• Develop and lead the safety data review process, including review of Individual Case Study Reports and aggregate data
• Be responsible for signal detection and analysis, and providing a proactive safety analysis plan for risk assessment, including monitoring adverse event reports, trends and frequencies, and assessment of various datasets
• Develop and implement risk management strategies and plans
• Review and provide pharmacovigilance input for regulatory submissions including; INDs, NDAs, Advisory Meetings, and Periodic Safety Reports
• Develop in-house training programs on PV as needed
• Oversee Pharmacovigilance CROs


• MD, Pharm D, RN, MPH or PhD, with over 13 years of relevant life science industry experience, including a minimum of five years clinical experience and at least five to six years focused on pharmacovigilance in the US pharmaceutical industry
• Proficiency with pharmacovigilance and clinical safety regulations (US and EU) and guidelines (FDA and ICH), as well as thorough knowledge of MedDRA, and drug safety databases
• Ability to work independently and manage operational activities by outsourcing with appropriate external vendors
• Ability to objectively interpret, analyze and communicate medical and scientific data
• Hands-on individual who appreciates the opportunities offered by a small, fast-growing pharmaceutical company
• Excellent communication skills, resourcefulness, and personal organizational skills; with the proven ability to problem solve and use good judgment
• Strong commitment to proactive risk management and problem solving
• Appropriately inform and escalate risks upward
• Excellent leadership skills and practices
• Up to 10% travel required

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