Manager, Decision Support & Assistive Technologies
BeiGene
Basel
vor 3 Tg.

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.

Job Description : Company Overview :

Company Overview :

BeiGene, Ltd. (NASDAQ : BGNE; HKEX : 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics.

With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, 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

General Description :

Manage pharmacovigilance (Reporting) aspects for Global Patient Safety(GPS) and provide operational leadership. Ensure compliance with aggregate reports and providing regulatory data for users for reporting to regulatory agencies / partners, and adherence to BeiGene policies and applicable global (PV) regulations

Essential Functions of the Job :

Manage pharmacovigilance (Reporting) aspects for Global Patient Safety(GPS) and provide operational leadership. Ensure compliance with aggregate reports and providing regulatory data for users for reporting to regulatory agencies / partners, and adherence to BeiGene policies and applicable global (PV) regulations.

Minimum Requirements Education and Experience :

Bachelor's Degree in Science Information Systems or related field with at least 5 years of Pharmaceuticals / Biotechnology / IT experience

Master’s Degree in Science Information Systems or related field with at least 4 years of Pharmaceuticals / Biotechnology / IT experience.

Other Qualifications :

  • Provides expert guidance with in-depth knowledge of case processing, global pharmacovigilance regulations & guidelines.
  • Strong expertise regarding individual / aggregate safety data analysis.
  • Lead projects / solutions related to GPS reporting / data analysis / automation from business side (working with IT) from inception to delivery with minimal supervision.
  • Provide expert support for responding to inspection / audit / critical adhoc report requests on timely manner.
  • Analyze, prioritize business needs & timely response with delivery of required data / reports / information to users.
  • Oversee hosted / vendor operations related to change management, service requests & incident resolutions. Improve operational efficiencies and achieving high quality standards.
  • Develop and implement inspection / audit readiness program with the ability to provide quality data to users with quick turnaround.
  • Manage deviations and applicable corrective & preventive actions on timely manner to maintain compliance from reporting / automation frameworks.
  • Identify impact analysis of routine MedDRA dictionary upgrades on reporting framework. L
  • Lead the validation of required aggregate safety reports.
  • Provide training & technical support for existing reports, dashboards, or other tools.
  • Act as a training resource to departmental staff on use of current & future reporting tools.
  • Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution;
  • demonstrating leadership; commitment and dependability; and providing technical expertise.

  • Act as a departmental resource by researching and consulting with others within or outside of the department to resolve issues within the Reporting framework / tools.
  • Assist in the development of SOPs for Reporting department to ensure compliance with global pharmacovigilance requirements.
  • Assist with inspections, internal and external audits (GPV / GCP / Vendors).
  • Computer Skills :

  • Expertise in technological tools like SQL Server, Oracle, Databricks, Python, R, Spotfire, Power BI and automation tools is a plus.
  • Other Requirements :

  • Minimum of 5 years of working experience in Pharmacovigilance / Drug Safety with sound understanding of case processing, global health authority regulations / guidance’s preferred
  • Experience of Veeva Safety (Preferred) / ARISg / ARGUS or equivalent education, training & experience
  • Experience of SAP BusinessObjects reporting tool to create & generate reports.
  • Travel : Less than 10%

    Supervisory : NA

    Qualification Required :

    Competencies :

    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.

    Follow Us on !

    Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Klicke auf "Weiter", um unseren Datenschutz-und Nutzungsbestimmungen zuzustimmen . Du kriegst außerdem die besten Jobs als E-Mail-Alert. Los geht's!
    Weiter
    Bewerbungsformular