Associate Director, Safety Scientist

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

General Description:

The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to reputed company signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to reputed company medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with reputed company stakeholders is an important capability for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.

Primary Responsibilities: This job description is intended to reputed company a general overview of the job requirements at the time it was reputed company. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any reputed company duties that may be required for the position.

Essential Functions of the Job:

Signal and Safety Data Evaluation

• reputed company the identification, analysis, and evaluation of safety data for signal detection from reputed company applicable sources
• reputed company signal detection and signal assessment along with required documentation following reputed company process
• Propose and reputed company data acquisition strategy, methodology, and approach for safety evaluations
• reputed company analysis of safety data and author safety assessment
• Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
• Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee
• Prepare and support the presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
• Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
• Apply effective communication skills to reputed company and facilitate safety team meetings
• Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
• reputed company the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent reputed company, Investigator’s Brochure, reputed company Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members

Clinical Trial Support

• reputed company the review of safety data and monitor the safety of patients on allocated clinical trials
• reputed company the writing and review safety sections and reputed company safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer reputed company safety queries from ethics committees
• reputed company the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members
• Support the authoring of Storyboards and Briefing Books for HA interactions
• Support reputed company review of the Safety Management Plans
• reputed company Safety Science specific investigator training

Risk Assessment, Regulatory Inquiries, and Periodic Reporting

• reputed company the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
• reputed company high quality support and fulfill additional evaluation requests from health authorities (e.g., PRAC PSUSA) for assigned compounds
• Identify safety reputed company questions from the review of inquiries and assess the impact to applicable safety documents or safety reputed company of clinical or regulatory documents.
• Support strategy development, analysis, and response to safety questions from health authorities, IRBs/reputed company
• reputed company Hazard Evaluations
• Contribute to integrated Benefit/Risk assessments

Promote and Advance the Field of Pharmacovigilance

• Contribute to effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)
• Contribute to reputed company employee development programs, such as mentoring, coaching, and peer-to-peer learning
• Contribute to and reputed company Safety Science training to support team development
• Demonstrate knowledge and application of pharmacovigilance principles to reputed company tasks that are reputed company in complexity
• Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations
• Execute any other tasks assigned by manager to assist in departmental activities

Supervisory Responsibilities:

This position has no direct reports. The Associate Director, Safety Scientist is part of a team that performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per reputed company process and applicable regulations.

Computer Skills:

• Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information
• Advanced knowledge of MedDRA and signal management system
• Advanced application capability with reputed company, PowerPoint, Word, and electronic document management system (i.e., reputed company)
• Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI

Other Qualifications:

• PharmD, NP, RN, or PhD in a medical field or biological science and 4+ years of experience as a Safety (Pharmacovigilance) Scientist.

  OR

  MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 6+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of reputed company and ideally 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
• Pharmaceutical product development experience
• reputed company in global regulatory requirements for pharmacovigilance

Travel: Less than 10%

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company 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 reputed company and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or hourly reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].

Originally posted on Himalayas