Senior Manager, Safety Science

Employer
Celgene
Location
Summit, NJ
Posted
Jun 13, 2018
Ref
1801904
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- NJ- Summit East


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary:

The Senior Manager is responsible for safety surveillance activities for compounds in clinical development and for post-marketed products during the implementation and execution of clinical trials, through review of data from multiple sources, including clinical trial and safety databases, and the literature to support the following: clinical protocols, informed consent forms, Investigator's Brochures, Safety Management Teams, and other safety evaluations. 

Key Responsibilities:

Clinical Trial Support:

  • Leads the execution of all operational safety-related clinical trial activities, and may serve as the safety compound lead.

  • 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 Workaids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, and 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.

  • Supports various process improvement and cross-functional initiatives for both Trial Safety Science and GDRSM, which may include contributing to the development and periodic update of SOPs and Work Practices.

  • Contributes to safety activities between Trial Safety Science and internal / external partners; represents GDSRM in internal and external cross-functional settings.

    Compound Support:


  • Supports signal detection and 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.

  • 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.

  • May contribute to the content of aggregate safety reports (PSUR/DSUR) and Investigator's 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.

Departmental Activities:

  • Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication.

  • Support preparation for regulatory inspections with evaluation of current processes and documentation.

  • Liaise with all TA staff and maintain an effective and collaborative product safety team.

  • Support hiring, orientation, management, mentorship, and development of staff.

    Cross-functional Activities:


  • Provides safety training to site and study personnel, and responds to ad hoc Investigator / IRB / EC Queries.

  • Supports various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include input to the development and periodic update of SOPs and Work Practices.

  • Interacts with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management.

Key Relationships:

  • Department staff, peers and management

  • Lead Product Safety Physicians

  • Clinical Operations

  • Data Management

  • Clinical Research Scientists

  • Medical Writing

  • Case Management / LDSO

  • Global Medical Affairs

  • Regulatory Affairs

  • Clinical Quality Assurance

Governance:

  • Participate and/or provide input to materials and strategies at meetings including but not limited to: SMT - Safety Management Teams, DMC - Data Monitoring Committees (internal or external), Clinical Study Team.

Skills/Knowledge Required:

  • Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience.

  • At least 4-6 years of relevant pharmaceutical industry experience, of which at least 2 must have been in Drug Safety.

  • Previous experience in safety or clinical development/operations is required.

  • Working knowledge of the following: GCP & ICH Regulations, global safety environment, electronic data collection in clinical trials, and international regulations and guidance documents.

  • Good understanding of the drug development lifecycle, from clinical development through post-approval.

  • Ability to utilize clinical judgement and interpret medical safety data to assess safety issues within the context of the product's benefit/risk profile.

  • Well-developed oral and written communication skills with the ability to manage multiple studies across compounds/projects simultaneously.

  • Experience working in a cross-functional environment.

  • Experience manipulating, understanding, and integrating large and complex data sets from multiple sources to answer specific questions.

  • Experience working with ARISg, Business Objects, data review tools, MedDRA coding, SMQs

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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.