AVEO Oncology
Senior Manager, Pharmacovigilance Operations
AVEO Oncology, Boston, Massachusetts, us, 02298
JOB TITLE:
Sr Manager, Pharmacovigilance Operations
DATE PREPARED:
9/23/2024
JOB SUMMARY:
The Sr. Manager, Pharmacovigilance Operations provides functional area and operational support of assigned developmental and/or marketed product(s). This position will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks, contributes to safety-related reports (DSURs, PBRERs, PADERs, RMPs), assists with signal surveillance activities and literature surveillance, and contributes safety information to regulatory submissions. This position may also be cross-trained to participate in other regulatory functions.
PRINCIPAL DUTIES:
Under the supervision of the Directors of Pharmacovigilance Operations, provide vendor oversight with focus on quality and regulatory compliance for submission of all pharmacovigilance-related information.
Review aggregate safety reports for quality and content in conjunction with Aveo Regulatory Affairs.
Support clinical trial and commercial teams, both internal and external.
Support the Aveo PV owned Contact Center which receives both adverse events and product quality events.
Review literature for identification of potential safety issues.
Participate in departmental development activities including SOP and Work Instruction development, Audits / Inspections, and regulatory submissions.
Assist in management and communication with external vendors responsible for case processing activities including quality review of all cases.
Other duties as assigned.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
Education
PharmD or advanced healthcare degree (MS, BSN), or equivalent professional experience preferred.
Required/Essential
US based.
Strong understanding of Quality Management, CAPA and Effectiveness Checks and risk based mitigation.
Attention to detail with excellent understanding of GxP requirements with respect to quality and compliance.
Minimum 5 years’ experience in Argus safety data base including case processing, quality review, narrative writing and query management.
Ability to function in dynamic and evolving environment within a growing pharma organization.
Self-starter, able to jump in and offer solutions, ideas and best practices.
Minimum 5 years of experience in pharmacovigilance in the CRO setting, prefer 2-4 years in the Sponsor arena, or relevant experience including data analysis and vendor oversight.
Ability to analyze, interpret, and summarize moderately complex data with general oversight.
Exhibits firm comprehension of pharmacovigilance and drug development processes and requirements.
Demonstrates strong ability to communicate effectively in a matrix environment.
Exhibits ability to multi-task effectively, e.g., ability to complete work in a resourceful, self-sufficient manner while maintaining a strong focus on the specific tasks demanding resources and attention.
Demonstrates solid written and oral communication skills and sound attention to detail.
Possesses computer skills to support use of electronic systems and development of writing deliverables.
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr
Sr Manager, Pharmacovigilance Operations
DATE PREPARED:
9/23/2024
JOB SUMMARY:
The Sr. Manager, Pharmacovigilance Operations provides functional area and operational support of assigned developmental and/or marketed product(s). This position will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks, contributes to safety-related reports (DSURs, PBRERs, PADERs, RMPs), assists with signal surveillance activities and literature surveillance, and contributes safety information to regulatory submissions. This position may also be cross-trained to participate in other regulatory functions.
PRINCIPAL DUTIES:
Under the supervision of the Directors of Pharmacovigilance Operations, provide vendor oversight with focus on quality and regulatory compliance for submission of all pharmacovigilance-related information.
Review aggregate safety reports for quality and content in conjunction with Aveo Regulatory Affairs.
Support clinical trial and commercial teams, both internal and external.
Support the Aveo PV owned Contact Center which receives both adverse events and product quality events.
Review literature for identification of potential safety issues.
Participate in departmental development activities including SOP and Work Instruction development, Audits / Inspections, and regulatory submissions.
Assist in management and communication with external vendors responsible for case processing activities including quality review of all cases.
Other duties as assigned.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
Education
PharmD or advanced healthcare degree (MS, BSN), or equivalent professional experience preferred.
Required/Essential
US based.
Strong understanding of Quality Management, CAPA and Effectiveness Checks and risk based mitigation.
Attention to detail with excellent understanding of GxP requirements with respect to quality and compliance.
Minimum 5 years’ experience in Argus safety data base including case processing, quality review, narrative writing and query management.
Ability to function in dynamic and evolving environment within a growing pharma organization.
Self-starter, able to jump in and offer solutions, ideas and best practices.
Minimum 5 years of experience in pharmacovigilance in the CRO setting, prefer 2-4 years in the Sponsor arena, or relevant experience including data analysis and vendor oversight.
Ability to analyze, interpret, and summarize moderately complex data with general oversight.
Exhibits firm comprehension of pharmacovigilance and drug development processes and requirements.
Demonstrates strong ability to communicate effectively in a matrix environment.
Exhibits ability to multi-task effectively, e.g., ability to complete work in a resourceful, self-sufficient manner while maintaining a strong focus on the specific tasks demanding resources and attention.
Demonstrates solid written and oral communication skills and sound attention to detail.
Possesses computer skills to support use of electronic systems and development of writing deliverables.
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr