Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Expedited Reporting Oversight in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Global Expedited Reporting Oversight, working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include:
- Leads and provides direction for expedited reporting requirements and processes for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs and Ethics Committees Leads the strategy and execution of business processes, accountability and development of policies, procedures and tools to facilitate efficient operations and compliant reporting of ICSRs to regulators, LOCs and internal and external partners and vendors
- Ensures the integrity of reporting rules in the safety database to enable compliant ICSR reporting.
- Provide leadership and oversight to vendors performing ICSR submissions for Takeda ensuring adverse event information is processed according to company timelines and quality standards.
- Manage and oversee Takeda requirements for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs and Ethics Committees; Ensure accuracy of safety system configuration against the reporting requirements.
- Responsible for communication and collaboration with Global GPSE functions and regulatory intelligence to assist with seamless systems for compliant reporting to Health Authorities
- Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to Global Health Authorities, alliance partners, LOCs, ECs, vendors and investigators and development of and implementation of a methodology for regular quality assessments.
- Oversee and manage communication with alliance partners, vendors, CROs and internal partners regarding the evaluation and processing of ICSRs
- Support Global Pharmacovigilance Operations in internal audits and Health Authority inspections related to global expedited reporting and submissions
- Review and approve Alliance Partner safety data exchange agreements for appropriate ICSR safety reporting processes and exchanges ensuring compliance with global expedited reporting requirements.
- Responsible for update of reporting requirements and ensuring the Global Safety Database configuration is updated with new or revised Alliance Partner safety data exchange agreements requirements
- Ensure compliance with global regulatory requirements by implementation of appropriate SOPs, processes, reporting reference materials and metrics
- Monitor performance, accuracy, compliance, and training on Global Expedited Reporting and Submissions requirements
- Lead PV relationship with the Vendor and/or vendors performing PV Processes and Global Expedited Reporting and Submissions to ensure compliance with SLAs
- Support LOCs in PV tasks responding to queries and requests regarding case handling and expedited reporting
- Establish and manage vendor oversight procedures\
- Partner with QA to establish and manage vendor quality agreement procedures related to PV Processes and Global Expedited Reporting and Submissions.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelors required. Advanced degree in scientific/medical field preferred.
- Minimum 8 years pharmaceutical or health care related industry experience required.
- Minimum 6 years PV experience with 4 years experience working in in case processing or case submissions or similar experience
- Good cross cultural understanding and experience
- Experience in matrix management and well developed skills in team-building, motivating and developing people.
- Demonstrated skills in negotiation and consensus decision making
- Critical thinking and analytical skills and ability to make key decisions
- Demonstrated effectiveness in external partner relationship management
- Understanding of medical/scientific terminology
- Excellent knowledge of PV regulations for the global pre and post-market
- Experience with safety databases, including search and code dictionaries and performing expedited E2B reporting to regulatory authorities
- Excellent written/oral communication skills
- Accuracy and attention to detail
- Flexible mindset
- Team worker with collaborative approach
- Ability to prioritize under pressure
- Well developed organizational skills
- Some travel to global Takeda sites may be required.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.