Bristol-Myers Squibb Company

Manager SAFETY REVIEWER

Location
Hopewell, NJ, US
Posted
Jul 17, 2018
Ref
R1506457
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives

Responsibilities:
  • Lead team members to design, develop, implement and monitor ICSR PV reporting processes in accordance with global Health Authority requirements.
  • Ensure team member Book of Work activities are properly allocated and aligned with functional area priorities.
  • Collaborate with Stakeholders to ensure ICSR activities are completed in a timely manner in the chain of deliverables.
  • Interact with Vendor to manage open inventory of ICSRs and delegated assignments and projects.
  • Continuously evaluate ongoing ICSR processes for global PV reporting compliance and work product quality and introduce innovative solutions to issues identified.
  • Collaborate with Stakeholders having a collaborative mindset of quality and inspection readiness.
  • Participate in Audits and Inspections and construct CAPAs when necessary.


Experience/Knowledge Desired:
  • B.S. or B.A. in Natural Sciences (Biology, Chemistry), BSN or RN in Nursing or Pharm.D., RPh. in Pharmacy.
  • Minimum 5 years experience in pharmacovigilance Individual Case Safety Reporting processes and procedures for cases originating from spontaneous, literature and clinical trial sources.
  • In-depth knowledge of global ICSR reporting requirements including FDA, EMA and PMDA.
  • Knowledge of associated ICSR activities such as reconciliations, PQC Reporting, Pharmacovigilance Agreements, Aggregate Reporting Requirements, Medical Device -Combination Product Reporting.
  • Experienced with developing ICSR process conventions in accordance with safety database architecture.
  • Demonstrated ability to complete multiple assignments with competing priorities.
  • Capable of collaborating with different functional areas to complete project deliverables.
  • Experience in leading a group of team members to complete complex activities in short timeframes.
  • Ability to create innovative solutions which simultaneously ensure compliance and create value.
  • Ability to allocate deliverables among team members to ensure timely and quality completion of task.
  • Attention to detail with excellent planning, time management and organizational skills.