Job details
Job type full-time
Full job description
Beigene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionalsWhen considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancerGeneral description: this role is responsible for the ongoing management and support for the safety database and other associated safety gateways and data repositoriesThe individual will provide technical expertise, support, and guidance to the beigene global product safety organization to facilitate the processing and submission of icsrs, aggregate safety reports, safety analyses, and signal detectionIn addition, this individual will respond to time-sensitive requests from internal and external stakeholders such as drug safety/pv scientists, clinical science, clinical operations, regulatory authorities and business partnersScope and deliverables:
Support and manage the proper function, maintenance, and validation of beigene safety systems (safety database and other supporting systems) and adherence to beigene policies and applicable global (pv) regulations.
Manage changes to the systems under beigene change control policy, including configuration change and system upgrades.
Support routine dictionary upgrades.
Manage the development and validation of required aggregate safety reports.
Contribute to ad hoc report specification, development, validation, and implementation and maintain required validation documents.
Validate, implement, and maintain data transmission gateways with regulatory authorities and partners.
Act as a training resource to departmental staff on the use of safety system.
Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution; demonstrating leadership and providing technical expertise.
Serve in consultative role within or outside of the department to resolve issues pertaining to the safety system and interface with other pv tools.
Assist in the development of sops for the safety system & its maintenance
Participates in the implementation of additional safety system informatics systems including signal detection and surveillance tools, safety data warehouse and reporting systems.
Assist with internal and external audits of the safety system
Required education:
Bachelor’s degree in computer science or related field, with at least 5-7 years of it or direct drug safety systems support experience
Six-sigma certification desirable
Required experience:
Minimum of 5-7 years of experience working within pharmacovigilance/drug safety within the
Biotech/pharmaceutical industry
Familiarity with global pharmacovigilance regulations and guidelines including but not limited to eu good pharmacovigilance practices (gvp)
Awareness of the principles of six-sigma/ business process management desirable
Other qualifications:
Strong interpersonal and presentation skills, including the ability to liaise with senior leaders
Excellent oral and written communications
Ability to deal with ambiguity and make decisions within a high-growth, rapidly evolving environment
Computer skills:
Knowledge of veeva safety strongly preferred.
Ability to write advanced sql code (with applicable support).
Proficiency with standard desk-top computing programs (i.e., microsoft word, microsoft excel, microsoft power-point, and microsoft access) is required.
Ability to support and suggest workspace repository solutions for secure, confidential pv data & documents (e.g.; sftp servers, secure pv sharepoint sites)
Travel: 10-15% competencies: ethics - treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational valuesPlanning/organizing - prioritizes and plans work activities; uses time efficientlyCompletes administrative tasks correctly and on timeFollows instructions and responds to management directionCommunication - listens and gets clarification; responds well to questions; speaks clearly and persuasively in positive or negative situationsWrites clearly and informativelyAble to read and interpret written informationTeamwork - 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 succeedContributes to building a positive team spirit; shares expertise with othersAdaptability – able to adapt to changes in the work environmentManages competing demandsChanges approach or method to best fit the situationAble to deal with frequent change, delays, or unexpected eventsTechnical skills - assesses own strengths and development areas; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with othersDependability - 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 planQuality - demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure qualityAnalytical - synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement dataProblem solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfullyProject management - communicates changes and progress; completes projects on time and budgetWe are proud to be an equal opportunity employer and we value diversityBeigene 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 lawAll employment is decided on the basis of qualifications, merit, and business need.
