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 a Sr. Manager PV Processes in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Manager PV Processes working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include:
- Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.
- Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
- Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review; call centers
- Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.
- Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards
- Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable
- In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs
- In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements
- Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level
- Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
- Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
- Support LOCs in PV tasks responding to queries and requests regarding case handling
- Interface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
- Direct relationship with and output of BPO partner(s) in accordance with SLA
- Liaises with financial / project management for budget planning
- Approve actual invoices and confirm accuracy of spend and bills
- Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
- Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
- Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
- Adherence to KPIs and SLAs
- Forecast demand
- Issue escalations
- Continuous improvement initiatives
- Change management
- Manage / review delivery against MSA terms
- Monitor global KPIs and SLAs
- Ensure quality of deliverables across teams
- Represent voice of vendor to PV function
- Provide guidance to delivery teams
- Maintain operating manual (describing operating rules with vendor)
- Lead change management and ongoing training
- Establish and manage vendor oversight procedures
- Partner with QA to establish and manage BPO vendor quality agreement procedures include vendors performing case management/intake activities or literature review and surveillance
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s required. Advanced degree in scientific/medical field preferred.
- Good cross cultural understanding and experience
- Experience in people management and well developed skills in teambuilding, 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
- Good knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVP
- Experience with safety databases, including MedDRA and WHO Drug
- 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
RN or Pharmacist preferred
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.