Senior Safety Associate

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:

-Utilize knowledge of global Health Authority reporting requirements as well as departmental processing conventions to ensure compliance of Individual Case Safety Reports (ICSR) processing team.

-Assess incoming Stakeholder requests associated with ICSR issues and prioritize requests according to global regulatory reporting timelines.

-Collaborates with various Stakeholders and Customers to ensure ICSR issues are addressed and resolved in a timely manner.

-Perform oversight of various ICSR processing activities executed by Vendors.

-Develop efficient and value added solutions to enhance effectiveness of Vendor oversight processes.

-Develop ICSR processing conventions in accordance with global reporting requirements and safety database architecture.

-Serve as Subject Matter Expert on selected ICSR processing topics and assist Stakeholders via providing pharmacovigilance reporting perspective.

-Provide mentorship and training as needed to Vendor team members.

Experience and Skills Required:

B.S. or B.A. Natural Sciences (Biology, Chemistry), BSN or RN in Nursing or Pharm D.

-Minimum 2 years experience in pharmacovigilance Individual Case Safety Report (ICSR) processing

-In-depth knowledge of global ICSR reporting requirements including FDA, EMA and PMDA

-Knowledge of associated ICSR activities such as reconciliations, PQC reporting and Pharmacovigilance agreements

-Organizes workload in order to prioritize most urgent deliverables.

-Exercises a high degree of adaptability in addressing ambiguous and complex demands.

-Demonstrates strong teamwork ethic to ensure processes, procedures and best practices are consistent across teams.

-Proven track record of completing projects within defined timelines.

-Contributes ideas and is committed to a continuous improvement philosophy.

-Embraces technology to facilitate continuous improvement goals.

-Maintains a customer service focus with both internal and external Stakeholders.

-Employs effective oral and written communication skills to ensure alignment of processes across teams.