Senior Manager, PV Operations

OBJECTIVE:

ACCOUNTABILITIES:

• 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, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s required. Advanced degree in scientific/medical field preferred

• Minimum 6 years pharmaceutical or health care related industry experience required

• Minimum 5 years PV experience with 3 years experience working with CROs, vendors, and relationship management required

• Global experience with CROs, vendors and relationship management 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

LICENSES/CERTIFICATIONS:

• RN or Pharmacist preferred

TRAVEL REQUIREMENTS:

• Some travel to global Takeda sites may be required

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.