Associate Medical Director, MCR, Case Review, PV & Drug Safety
Company: BeiGene, Ltd.
Location: Ridgefield Park
Posted on: February 17, 2021
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Job Description:
Associate Medical Director, MCR, Case Review, PV & Drug Safety
Ridgefield Park BeiGene 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. 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 post marketing
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. Essential Functions of the job: ---
Serves 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 Assessment of reported adverse events (AE) and serious
adverse events (SAE) providing company causality assessment
utilizing clinical and global introspection methodologies aligned
with global regulations 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
safety medical queries Review and approve Analysis of Similar
Events and 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
Product Safety Lead Physician/Safety Scientist and Medical
Monitors, and upper management as necessary Issue urgent medical
queries on urgent follow-ups, coordinating with Product Safety Lead
Physician and Medical Monitors as required Communicate with
investigators and other AE reporters for urgent medical queries and
follow-ups Provide medical input and review RSI in Investigator
Brochure Provides the medical input and review needed for the
creation aggregate reports (PBRER, DSUR, PADER) as needed to
support compounds in clinical development or post approval
Contribute to preparation and review answers to safety queries from
regulatory authorities and IRBs as needed Contribute to preparation
and review of any aggregate safety analysis in regulatory
submissions as needed Conduct training to new team members in
medical review and help in managing Medical Case Review team. May
act as Medical Safety Review functional representative on cross
functional projects Performance Metrics Contributing to metrics
addressing internal timeline & 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 Manage continuous improvement opportunities within Medical
Safety Review and ICSRM management Contribute to training,
oversight monitoring, performance metrics review of ICSR vendor
activities where applicable Key Relationships: Product Safety Lead
Physician, Safety Scientists, Safety Study Lead, ICSR and ASR
Management, Clinical Development, Clinical Operations, Safety OPS,
Safety Systems Supervisory Responsibilities: -- no direct
management responsibilities, but may be responsible for managing
medical case review workload, distribution and monitoring workflow
Knowledge, Skills and Education Required: ---MD, DO or MBBS or
other international equivalent ---Medical case review experience
and prior biopharmaceutical industry experience preferred ---2-4
years clinical experience, including training required ---1-3 years
drug safety experience as medical safety review physician; other
pharmaceutical industry MD experiences may be considered
Competencies and Knowledge: --- Ability to comply with Global
regulatory requirements (i.e. ICH, GVP, FDA 21CFR312, GCP, NMPA
Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and
submissions of pharmacovigilance individual case safety reports and
aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other
global regulatory authorities/national competent authorities
---Clinical knowledge of therapeutic area patient populations and
drug class is preferred ---Ability to work in technical safety
systems including Argus with electronic workflow and medical coding
frameworks, MedDRA, WHO Drug, ICD-10 ---Thorough appreciation of
the utilization of aggregate safety data Ethics - Treats people
with respect; Inspires the trust of others; Works with integrity
and ethically; Upholds organizational values. Planning/Organizing -
Prioritizes and plans work activities; Uses time efficiently.
Completes administrative tasks correctly and on time. Follows
instructions and responds to management direction. Communication -
Listens and gets clarification; Responds well to questions; Speaks
clearly and persuasively in positive or negative situations. Writes
clearly and informatively. Able to read and interpret written
information. Teamwork - Balances team and individual
responsibilities; Gives and welcomes feedback; Contributes to
building a positive team spirit; Puts success of team above own
interests; Supports everyone's efforts to succeed. Contributes to
building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment.
Manages competing demands. Changes approach or method to best fit
the situation. Able to deal with frequent change, delays, or
unexpected events. Technical Skills - Assesses own strengths and
development areas; Pursues training and opportunities for growth;
Strives to continuously build knowledge and skills; Shares
expertise with others. Dependability - Follows instructions,
responds to management direction; Takes responsibility for own
actions; Keeps commitments; Commits to long hours of work when
necessary to reach goals; Completes tasks on time or notifies
appropriate person with an alternate plan. Quality - Demonstrates
accuracy and thoroughness; Looks for ways to improve and promote
quality; Applies feedback to improve performance; Monitors own work
to ensure quality. Analytical - Synthesizes complex or diverse
information; Collects and researches data; Uses intuition and
experience to complement data. Problem Solving - Identifies and
resolves problems in a timely manner; Gathers and analyzes
information skillfully. Project Management - Communicates changes
and progress; Completes projects on time and budget. Computer
Skills: --Working knowledge of Microsoft Office Suite (e.g. Excel,
Powerpoint, Visio, etc), familiarity with safety database ARGUS and
with MedDRA Other Qualifications: Excellent communication skills
(verbal and writing); Clear and confident presentation skills;
ability to network and partner within global organizations; results
oriented and strong attention to detail Travel: less than 5% We are
proud to be an equal opportunity employer and we value diversity.
BeiGene does not discriminate on the basis of race, religion,
color, sex, gender identity, sexual orientation, age,
non-disqualifying physical or mental disability, national origin,
veteran status or any other basis covered by appropriate law. All
employment is decided on the basis of qualifications, merit, and
business need. Posted 2 Days Ago Full time R5465 About Us BeiGene
is a global, commercial-stage, research-based biotechnology company
focused on molecularly targeted and immuno-oncology cancer
therapeutics. Currently employees are located in APAC, United
States and Europe. BeiGene is advancing a pipeline consisting of
novel oral small molecules and monoclonal antibodies for the
treatment of cancer. BeiGene is working to create combination
solutions aimed at having both a meaningful and lasting impact on
cancer patients. For more information, see www.beigene.com.
Keywords: BeiGene, Ltd., Tenafly , Associate Medical Director, MCR, Case Review, PV & Drug Safety, Executive , Ridgefield Park, New Jersey
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