BioCurious Message Board › Career Networking
San Jose, CA
To kick off the new year hiring spree here's a post forward from my linked in for those of us looking for cash or in between ventures. I didn't work in depth with this recruiter but if the below matches up with your expertise/interest then I'd suggest you contact Naveen at <firstname.lastname@example.org> and let him know I referred you. They are also looking for a more junior "Research Associate" position for a shorter contract.
Job Title: Pharmacovigilance Scientist
Location: San Francisco, CA
Duration: 12+ Months
The Pharmacovigilance Science and Risk Management Group has responsibility for overall pharmacovigilance monitoring, safety management processes and strategy, aggregate safety data analysis and aggregate safety report production and review, responding to internal and external safety queries, liaising with business partners and other internal departments, representing pharmacovigilance science on cross functional teams and strategically leading, coordinating and implementing risk management activities throughout the lifecycle of company’s products.
The PV Scientist supports the scientific and medical functions within GPRM, and is responsible for coordinating and contributing to the strategy, design and implementation of processes to manage safety profiles for the assigned products, in collaboration with other functions within GPRM, other relevant departments and business partners. The PV Scientist will provide PV representation and support clinical and other cross-functional teams, and provide pharmacovigilance input for analysis, aggregate summarization, and tracking/evaluation of safety topics for internal and external stakeholders.
This position is based in South San Francisco.
• Support scientific evaluation of the safety profiles of the assigned products through pharmacovigilance activities.
• Support proactive safety surveillance of company’s products through the planning and execution of pharmacovigilance tasks.
• Contribute to the development and update of signal detection strategy for the assigned products.
• Coordinate and participate in Safety Management Team (SMT) meetings, including internal and/or joint alliance meetings, as needed.
• Contribute to aggregate data analysis of global safety data to maintain up-to-date safety profiles of company’s products throughout their lifecycles.
• Actively participate in preparation/update, analysis and writing of ad-hoc and scheduled aggregate safety documents and reports (including ICFs, IBs, DSURs, IND ARs).
• Assist in authoring, signal evaluations and management of responses to Health Authorities related to the assigned products.
• Assist in monitoring of medical and scientific literature for published articles relevant to the safety profile of the assigned products.
• Assists in regulatory filing activities, as needed.
• Perform quality control activities for deliverables produced by other PV Scientists, as needed.
• Support inspection and preparation for audit activities, as needed.
• Contribute to preparation and/or presentation of the safety review summaries/updates to internal and alliance stakeholders.
• Participate in planning and execution of PVS&RM projects under the direction of PVS&RM management.
• Provide pharmacovigilance input for scientific aggregate analysis, and assist in tracking/evaluation of specific safety topics for internal and external stakeholders.
• Actively contribute to PVS&RM representation on cross functional teams.
• Collaborate with team members and partners to ensure smooth completion of PV responsibilities and activities.
• Assist in preparation and authoring of ad-hoc regulatory reports, including the one prepared for Health Authorities.
• Review safety data via standard safety database outputs for signal detection.
• Assist in development of pharmacovigilance processes, assessment of practicalities and conduct/participate in training initiatives to ensure adherence, as needed.
• May need to assist in preparation of Risk Evaluation and Mitigation Strategy (REMS) plans and other pharmacovigilance activities.
Decision-making and problem solving requirements include:
• Ability to independently make informed decisions and demonstrate strong problem-solving skills.
• Attention to detail and ability to organize analyze and summarize/present required safety data.
• Ability to understand complex associations and provide constructive solutions to potential safety issues and/or signals.
The position reports to the Senior Director, PV Science and Risk Management, GPRM.