Senior Associate, PV Operations (Global Aggregate Reporting and Risk Management Plans)
Apply knowledge and expertise in the area of aggregate reporting and risk management documents. Serve as principal owner of Aggregate Safety Reporting (ASR) and Risk Management deliverables.
• Drives development and maintenance of a center of excellence for Pharmacovigilance Aggregate Reporting and Risk Management Deliverables.
• Contributes to the development and maintenance of core cross-organizational procedures for all aggregate reports (i.e. PSURs/PBRER, PADER, DSURs, SUSAR), aggregate report tables and listings globally as well as Risk management plans. Facilitate Aggregate Report production activities across CSPV and other organizations.
• Develop and maintain standard templates and processes for PV contributions to submission deliverables
• Contributes to the development and maintenance of efficient and robust procedures to drive quality, timeliness and compliance with regulations
• Provides technical expertise and guidance to authors and contributors of aggregate reports and risk management plans
• Prepare each version of the deliverable and maintain version control of the document. Request source documents from other departments. Create workflows for each of the ASRs and RMPs in the document management system.
• Lead projects to ensure all activities are completed on time and meet quality standards.
• Build a positive, collaborative team environment and lead by example, provide training and mentoring for team members as well as outside of GPV.
• Interface with other functional groups, such as Regulatory Affairs, Clinical Management/Clinical Development or other business units as needed
• Provide regular reports to Global Head of Aggregate Reporting on project metrics, requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.
• Participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies and/or other projects.
• Perform other activities as needs arise in the context of ASRs, RMPs or PV area
• Support ongoing QA activities
• Contribute to continuous improvement
• Schedule and lead 'lessons learned' meeting following ASR submission, as necessary
• Gather ASR approval signatures
• Ensure contributors are maintaining compliance with project plan time lines
• Ensure synchronization among ASRs as necessary
• Plan and coordinate time and resources needed for ASR creation
• Collaborate on the drafting of user guides for document management system. Collaborate on the drafting of key SOPs & WPs related to ASR processes
• Provide ASR compliance metrics to management
• Identify all personnel involved in ASR preparation prior to strategy meeting
• Extensive knowledge of US, ICH and EU PV and GCP regulations;
• Minimum 1-3 years of global aggregate report experience;
• Experience with CA Inspections (PV and GCP);
• Experience managing vendors;
• Experience working with Alliance Partners and managing Pharmacovigilance Agreements;
• Bachelor’s Degree minimum.
• Computer Skills: WORD, Excel, PowerPoint
• Strong written and verbal communication skills
• Excellent strategic decision making and analytic skills
• PharmD., Nurse Practitioner, Physician Assistant pharmacy or nursing degree is pref
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.