Associate Director / Director Safety Data Management

  • Otsuka Pharmaceuticals
  • Princeton, NJ, USA
  • Nov 04, 2017
Science

Job Description


Otsuka



Overview:

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.



OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Responsibilities:

Reporting to the Head of Global Safety Data Management (GSDM), this position will be responsible for ensuring the satisfaction of Global Pharmacovigilance (GPV) needs for the successful implementation of systems and processes in the support of GPV. This position will ensure that systems fulfill the desired compliance, business process, data integrity, quality, security and system governance objectives globally.

Roles and Responsibilities
  1. Undertake innovation and breakthrough thinking that leads to robust, efficient, scalable, cost-effective, "best in class" GPV solutions.
  2. Satisfactory implementations and management of changes to GPV systems managed by GSDM. Act as technical lead for requirement development, design, implementation and validation of systems, as needed.
  3. Responsible and accountable for day-to-day management of a global team of FTEs, contractors and vendors engaged in support and implementation of GPV systems.
  4. Responsible for development, implementation and oversight of processes and procedures relating to effective management of global systems with the objective of maintaining their validated state. This includes providing metrics measuring the efficiency and effectiveness of the team.
  5. Responsible and accountable for timely escalation of issues and concerns that impact the GPV business, collaboration and efficient working of the team to the Global Head of GSDM.
  6. Responsible for financial tracking against approved budget.
  7. Work in a highly collaborative manner with all GPV functional areas (PV Operations, Medical Safety, Affiliate Management, Compliance and Business Management) to understand their needs and translate them into prioritized plans for action.
  8. Negotiate and administer vendor, outsourcer, and consultant contracts and service agreements.
  9. Mentor and develop GSDM staff with the aim of developing the overall knowledge, skills and capabilities of the team.
  10. Work effectively with Otsuka internal and external stakeholders on cross-functional projects on behalf of GSDM.
  11. Communicate regularly with management and all users of information services and systems

Qualifications:

Knowledge
  1. At least 8 years direct experience supporting and then leading successful global Argus, Argus J and data migration implementations for large and medium-sized Pharma. Experience must include performing business process and requirements analyses, development of configuration strategies and hands-on configuration of safety systems with a strong focus on ensuring customer satisfaction.
  2. Demonstrated knowledge and experience in implementing solutions to meet global Pharmacovigilance regulatory requirements especially in the EU, US and Japan.
  3. Strong knowledge of industry best practices and trends relating to system implementation, infrastructure, computer system validation and organizational processes.
  4. Demonstrated ability to lead a team of staff and to manage multiple concurrent projects.
  5. Demonstrated 5 to 8 years strong project management knowledge and experience.

Skills
  1. Self-starter with the ability to cope with ambiguity and develop strategies to move forward given broad outlines of desired outcomes.
  2. Strong customer engagement and stakeholder management skills with the ability to build consensus across diverse teams by applying excellent communication and interpersonal skills, often requiring tact, diplomacy, and discretion. Strong understanding of global business cultures.
  3. Demonstrated leadership and management ability to engage teams in the accomplishment of defined goals.
  4. Strong analytical, problem solving and creative thinking skills with the ability to innovate.
  5. Demonstrated project management skills with experience in leading cross-functional teams. A PMP Certification is a plus.
  6. Bachelor's degree in Computer Science, Engineering or Business is required. An advanced degree in a technical discipline or business is highly desirable.
  7. At least 5 to 8 years' direct experience with Oracle's Argus Safety, Argus J, MedDRA up-versioning, system architecture, infrastructure, data migrations.

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