Adverum Biotechnologies
Director Pharmacovigilance
Adverum Biotechnologies, Redwood City, California, United States, 94061
Redwood City, CA
Clinical Development
Full TimeAdverum is seeking a Director of Pharmacovigilance who will be responsible for implementing and coordinating pharmacovigilance activities. This position will be a knowledge leader for Adverum and actively participate in safety related aspects of the product life cycle from development to post-marketing to ensure rigorous analysis, critical decision making, and communication of safety information to internal Adverum teams and regulatory authorities. It is expected that this person will develop a proactive, forward-looking program of communicating safety information and directions for safety product use to stakeholders both internal and external. Knowledge of safety operations and systems is important to this position.The person will be a key interface and participant with internal Adverum team such as Clinical Development, Clinical Operations, Regulatory, and Compliance/Quality. Documentation of the origin, ongoing history, and closure of safety issues will be critical.The person will ensure corporate compliance with domestic and international adverse event and safety issue reporting requirements, interpreting the medical significance of incoming safety information, and performing regular risk management assessments of assigned products.What You’ll Do:
Act as safety leader with responsibility for signal detection and assessment activities for Adverum.Signal summary reports.Tracking and using safety database tools for aggregating safety data.Leading cross functional teams to assess safety signals.Creation of action plans to mitigate/manage product risks.Responding to safety associated Health Authority requests.Development and maintenance of product Risk Management Plans (RMP).Monitor the safety profile of delegated products and recommend appropriate action including labeling amendments and risk management programs when warranted assess product specific adverse event information to determine required action based on internal policies.Providing medical assessment as relevant.Participation in maintaining and upgrading pharmacovigilance processes. These may include MedDRA maintenance, PV systems policies, and implementation of new regional and cross-regional PV regulations.Ensures corporate compliance with domestic and international adverse event and safety issue reporting requirements for delegated products.Prepare safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, annual safety reports, Investigator Brochures, Development Safety Update Reports (DSUR), and Annual safety update reports (ASUR), and other aggregate reports).Review ICFs, clinical study non-serious adverse event line listings and other study related documents containing safety information.May assist with approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals.Assists with contributing to safety components of strategic documents and to development of Target Product Profile (TPP).Act as the safety liaison/resource on study project teams for safety related issues relating to clinical development.Supervise PV activities and personnel related to licensing partners and CROs.Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities.Collaborates with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.Interacts with service providers as required to address safety queries, share best practices, and discuss new safety regulations.Provides regional support for activities associated with safety compliance, operations, and medical review as needed.About You:
MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 5+ years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required.Demonstrated knowledge of domestic and international ADE reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes.Demonstrated knowledge and proficiency with drug safety databases (i.e. ARISg or ARGUS)Proficiency with standard office skills and standard desktop computing programsExcellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with multiregional organizations.Highly organized and demonstrates understanding of workflow prioritization.Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility.Excellent understanding of clinical trial methodology, GCP and medical terminologyAttention to detail and quality focused with strong technical and problem-solving skillsStrong organizational and project management skillsStrong communication skills and the ability to operate effectively in an international environmentExcellent understanding of physiology, pharmacology, clinical study objectives, and the drug development processStrong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation
#J-18808-Ljbffr
Clinical Development
Full TimeAdverum is seeking a Director of Pharmacovigilance who will be responsible for implementing and coordinating pharmacovigilance activities. This position will be a knowledge leader for Adverum and actively participate in safety related aspects of the product life cycle from development to post-marketing to ensure rigorous analysis, critical decision making, and communication of safety information to internal Adverum teams and regulatory authorities. It is expected that this person will develop a proactive, forward-looking program of communicating safety information and directions for safety product use to stakeholders both internal and external. Knowledge of safety operations and systems is important to this position.The person will be a key interface and participant with internal Adverum team such as Clinical Development, Clinical Operations, Regulatory, and Compliance/Quality. Documentation of the origin, ongoing history, and closure of safety issues will be critical.The person will ensure corporate compliance with domestic and international adverse event and safety issue reporting requirements, interpreting the medical significance of incoming safety information, and performing regular risk management assessments of assigned products.What You’ll Do:
Act as safety leader with responsibility for signal detection and assessment activities for Adverum.Signal summary reports.Tracking and using safety database tools for aggregating safety data.Leading cross functional teams to assess safety signals.Creation of action plans to mitigate/manage product risks.Responding to safety associated Health Authority requests.Development and maintenance of product Risk Management Plans (RMP).Monitor the safety profile of delegated products and recommend appropriate action including labeling amendments and risk management programs when warranted assess product specific adverse event information to determine required action based on internal policies.Providing medical assessment as relevant.Participation in maintaining and upgrading pharmacovigilance processes. These may include MedDRA maintenance, PV systems policies, and implementation of new regional and cross-regional PV regulations.Ensures corporate compliance with domestic and international adverse event and safety issue reporting requirements for delegated products.Prepare safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, annual safety reports, Investigator Brochures, Development Safety Update Reports (DSUR), and Annual safety update reports (ASUR), and other aggregate reports).Review ICFs, clinical study non-serious adverse event line listings and other study related documents containing safety information.May assist with approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals.Assists with contributing to safety components of strategic documents and to development of Target Product Profile (TPP).Act as the safety liaison/resource on study project teams for safety related issues relating to clinical development.Supervise PV activities and personnel related to licensing partners and CROs.Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities.Collaborates with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.Interacts with service providers as required to address safety queries, share best practices, and discuss new safety regulations.Provides regional support for activities associated with safety compliance, operations, and medical review as needed.About You:
MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 5+ years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required.Demonstrated knowledge of domestic and international ADE reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes.Demonstrated knowledge and proficiency with drug safety databases (i.e. ARISg or ARGUS)Proficiency with standard office skills and standard desktop computing programsExcellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with multiregional organizations.Highly organized and demonstrates understanding of workflow prioritization.Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility.Excellent understanding of clinical trial methodology, GCP and medical terminologyAttention to detail and quality focused with strong technical and problem-solving skillsStrong organizational and project management skillsStrong communication skills and the ability to operate effectively in an international environmentExcellent understanding of physiology, pharmacology, clinical study objectives, and the drug development processStrong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation
#J-18808-Ljbffr