Associate Director, Medical Safety Review Physician

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Brazil Remote

General Description:

This position provides the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR) from any source including clinical trials, literature, post-marketing studies and postmarketing spontaneous adverse event reports in order to determine the event seriousness, expectedness, company causality, evaluate medical contents and case completeness, and identify potential safety signals at

single case level.

Key Relationships:

Product Safety Lead Physician, Safety Scientists, Safety Operations including Safety Study Lead, ICSR Management, Safety Systems, ASR Management, Clinical Development, Clinical Operations

Essential Functions:

Serve as safety medical expert to evaluate ICSRs for all company products either marketed or in clinical

development

Perform regular medical case review for all ICSRs reported from any source including clinical trials, literature,

post-marketing studies and post-marketing spontaneous adverse event reports to ensure complete and

timely review aligning with internal and external reporting timelines

Review all AEs and SAEs and determine whether the events are accurately reported and captured as what

occurred in patient clinically and confirm that events are correctly coded with MedDRA and confirm

seriousness criteria

Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct,

consistent interpretation and application to ICSRs

Review case narrative and medical contents for completeness, identify missing medical information or key

data that impact medical understanding and evaluation of the case, and issue medical safety queries

Provide company causality assessment of reported adverse events (AE) and serious adverse events (SAE)

utilizing clinical and global introspection methodologies aligned with global regulations

Review and approve Analysis of Similar Events, provide company comments and assessment with medical

analysis for SUSAR/IND Safety Reports

Provide overall case assessment and pharmacovigilance comment on ICSRs as needed

Identify important/critical cases with potential safety signals at single case level (i.e. first line signal

detection), escalating cases to Product Safety Lead Physician and Safety Scientist as necessary

Issue urgent medical queries on urgent follow-ups, coordinating with Product Safety Lead Physician, Safety

Scientist and Medical Monitors as required

Determine event term MedDRA coding for SAE reconciliation

Contribute to the preparation and review answers to safety queries from regulatory authorities and IRBs as

needed

Contribute to the preparation and review of any aggregate safety analysis in regulatory submissions as

needed

Conduct training for new medical review team members

Act as Medical Review functional representative and provide support to cross functional projects

Performance Metrics:

Contributing to metrics addressing internal timeline and work in progress performance (i.e. volume, quality, compliance and productivity metrics)

Quality Assurance:

Ensure effective ongoing quality assurance through ICSR review, feedback to ICSR team, issue escalation and continuous process improvement

Contribute to the root cause analysis of issues revealed by review of metrics

Support corrective and preventive actions stemming from compliance metrics review and other sources

Compliance, Standards and Training:

Contribute to identification of standards, processes, controlled documents (including SOPs, Work Instructions, etc.) aligning with established and developing regulatory requirements for ICSR medical assessment and management

Contribute to the development of compliance targets and their ongoing determination.

Contribute to and deliver training programs for Medical Safety Review Physician and ICSR personnel as required

Participate in and support internal and external audits and inspections including those by regulatory agency and business partners

Continuous Improvement:

Manage continuous improvement opportunities within Medical Safety Review and ICSRM management

Vendor Oversight

Contribute to training, oversight monitoring, performance metrics review of ICSR vendor activities where applicable

Minimum Requirements – Education and Experience:

MD, DO or MBBS or other international equivalent

Medical case review experience and prior biopharmaceutical industry experience preferred

Minimum of 2- 4 years Clinical experience, included training required

Minimum of 8-10 years pharmacovigilance experience preferred, including 2-3 years as a Medical Safety Review Physician is preferred; other MD experience in the pharmaceutical industry may be considered

Other Experience:

Excellent communication skills (verbal and writing); Clear and confident presentation skills

Supervisory Responsibilities:

No direct management responsibilities, managing medical case review workload, distribution and monitoring workflow

Travel: Less than 5%

Computer Skills:

Working knowledge of Microsoft Office Suite (e.g. Excel, PowerPoint, Visio, etc.), familiarity with MedDRA and safety database ARGUS

#LI-Remote

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork

Provides and Solicits Honest and Actionable Feedback

Self-Awareness

Acts Inclusively

Demonstrates Initiative

Entrepreneurial Mindset

Continuous Learning

Embraces Change

Results-Oriented

Analytical Thinking/Data Analysis

Financial Excellence

Communicates with Clarity