Project Specialist, Aggregate Safety Reporting

Celgene Corporation Summit , NJ 07901

Posted 12 months ago

Job Description: Req #: 1900920

Location: Summit, New Jersey, United States

Job Category: Medical

Work Location: 556 Morris Avenue 07901

Organization: Drug Safety

Employee Status: Full-time

Job Type: Regular

Responsibilities include, but are not limited to, the following:

  • Creating and maintaining the ASR project schedules

  • Ensuring all contributors are maintaining compliance with time lines

  • Tracking ASRs and their due dates

  • Plan, schedule, coordinate and lead kick-off, strategy and comment resolution meetings

  • Plan, schedule and coordinate resources (people and time) needed for ASR creation

  • Identify all personnel involved in ASR preparation prior to kick-off meeting

  • Lead ongoing ASR production meetings

  • Solicit information for ASRs from identified contributors via email

  • Create workflows (review and approval) for each of the ASRs in the document management system

  • Liaising with PV/EPI group supporting approved products and activities

  • Liaising with TSS group supporting development products and activities

  • Liaising with Regulatory Affairs to coordinate contributions for and synchronization of periodic reports

  • Liaising with other contributing groups as appropriate

  • Schedule additional meetings as needed to resolve issues

  • Collaborate on the drafting of key SOPs & WPs related to ASR processes

  • Perform other activities as needs arise in the context of ASRs

  • Representing ASR and collaborating with business partners to promote streamlined processes

Skills/Knowledge Required:

  • Education: BA or BS in Business, Engineering, Computer Science, Health Science or similar

  • Certification: PMP certification is a plus

  • Experience: One to two years relevant experience in pharma/biotech, preferably in PV; One or more years relevant experience in project planning desirable

  • Excellent skills and proficiency with Microsoft Office products: Word, Outlook, Project, Excel, PowerPoint required; Visio and Livelink (or similar document management platform) desirable

  • Experience with safety databases (ARISg or similar) and reports is desirable

  • Experience with document management systems and/or electronic shared work spaces, e.g., SharePoint

  • Ability to identify existing or potential deficiencies in procedures, and recommend solutions for process improvement

  • Strong communication skills (both oral and written) and the ability to interact with various levels, both within GDSRM as well as other parts of the organization

  • Knowledge of US, EU and ROW PV regulations

  • Demonstrated ability to work independently with effective presentation and interpersonal skills to ensure a team-oriented approach

  • Ability to demonstrate a familiarity with general principles of PV

  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager Safety Science

Apex Systems

Posted 1 week ago

VIEW JOBS 2/16/2020 12:00:00 AM 2020-05-16T00:00 Job Description Job #: 1048733 Senior Manager, Safety Science: Key Responsibilities: General Responsibilities * Provides support to LPSP in activities relating to monitoring and management of Product's emerging safety profile * Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication * May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings * Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking * Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile * Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.) * May provide input and support safety publication strategy Trial Safety Support * Leads execution of all operational safety-related clinical trial activities, and may serve as the Lead Safety Scientist for a compound * Supports/May lead the strategy for surveillance activities, as appropriate * Participates in ongoing SAE reconciliation between the safety and clinical databases * Completes study-level activities generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF * Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities * Coordinates the management and preparation for DMC preparation, documentation, and logistical support * May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR Compound Level Safety Support * May contribute to the content of Aggregate Safety Reports (PSUR/DSUR) and Investigator Brochures in accordance with regulatory requirements and standard operating procedures * Obtains integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician for a compound * May support the lead product safety physician with the management of the product's benefit/risk profile Post-marketing Support * May contribute to development of signal detection strategy with consideration for integrating quantitative data mining methods and qualitative approaches * May contribute in development of risk mitigation strategies by providing key safety findings and/or supportive data * May contribute to Safety Topic Review development by authoring certain sections * Contributes to ad-hoc regulatory safety requests preparation by obtaining data from various sources to assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile * Contributes to the content of aggregate safety reports (PSUR/DSUR), Risk Management Plans, and Events of Interest Surveillance Documents * Contributes to safety labeling activities for assigned products * Performs literature review and QC Requirements: * Pharmacy/Nursing (BSN, MS, PharmD) degree * At least 4 years of relevant pharmaceutical industry experience * Previous experience in Safety or Clinical Development or Operations * 2-4 years of experience within Drug Safety * Decision-Making & Change Agility * Communication/Writing * Time Management & Prioritization * Results-Drive * Self-Awareness & Perspective EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] . Apex Systems Summit NJ

Project Specialist, Aggregate Safety Reporting

Celgene Corporation