South San Francisco
California, United States of America
Based on identified risks and process gaps, the Pharmacovigilance (GVP) Vendor Lead, US Medical Affairs is responsible for developing and executing the strategic oversight plan for ensuring MAP and GVP Service Provider (SP) Pharmacovigilance (PV) compliance per health authority and global Roche requirements. The Pharmacovigilance (GVP) Vendor Lead, US Medical Affairs makes all decisions around the day-to-day operations of the oversight plan, and continuously monitors feedback to inform quality improvements and updates. The Pharmacovigilance (GVP) Vendor Lead executes the oversight plan within the framework set by the SP PV Oversight Manager and Head of SP PV Oversight.
• Liaise with business/functional units to influence the design of MAP and GVP SP processes ensuring adequate collection of safety data and their timely reporting to the safety unit.
• Perform SP risk assessments to ensure GVP and MAP SPs have Quality Management Systems (QMS) in place.
• Identifies risks and gaps within the SP process. Develops strategic oversight plans for ensuring PV compliance for MAP and GVP SPs, including risk mitigation strategies.
• Accountable for execution of SP Oversight Plan (SPOP).
• Acts as single point of contact for all SP communications.
• Makes all decisions around the day-to-day operations of the oversight plan.
• Continuously monitors feedback to inform quality improvements and updates.
• Act as Pharmacovigilance subject matter expert for MAP and GVP SP processes in the event of audit or regulatory inspections.
• Represents US affiliate on global workstreams or committees as required.
• Use appropriate metrics and quality checks to gain sufficient oversight of the MAP and GVP SP processes and its effectiveness, aiming to achieve a desired state of compliance.
• Oversee and support implementation of SP CAPAs, as appropriate.
• In collaboration with the vendor owner, perform at least annual site visits to GVP and MAP SPs.
• Communicates with vendor owner and SP regularly as part of communication plan to drive a desired state of collaboration.
• Escalates issues and risks as appropriate to vendor owner, SP PV Oversight Manager and/or SP PV Oversight Head as appropriate.
• Accountable for PV compliance for GVP or MAP SPs. Proprietary
• Attend teleconferences during international timezones, on an as-needed basis
Competencies Identified for Success:
• Ability to adapt in a regularly changing environment
• Experienced with engaging key stakeholders
• Strong organizational and project management skills
• Strong influencing skills and collaborative approach with peers and senior leaders
• Excellent communication skills, both written and oral
• Works effectively as a team member and promotes collaboration
• Appreciation for the importance of Pharmacovigilance compliance in pharma industry
• Understanding of Patient Support Programs and Market Research Progams Education, Experience, and Other Requirements:
• Life sciences degree BSc minimum (or >10 years’ experience in a similar role)
• 3+ years in pharmacovigilance or compliance-related role
• 12-15 years pharma experience / 10-13 years pharma experience with Masters or RN / 7-10 years with PhD/PharmD
• Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
• International travel required (~10% of time)
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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