Manager, PV Strategic Partner Management
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: July 8, 2025
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Job Description:
Join a Legacy of Innovation 125 Years and Counting! Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 125 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 18,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, under the Group’s 2025
Vision to become a “Global Pharma Innovator with Competitive
Advantage in Oncology,” Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. Job
Summary: Manage Local/Global Pharmacovigilance (PV) service
providers responsible for Call Center, individual safety case
processing, and aggregate reporting for DSI products, both
investigational and marketed. Maintains compliance with Global PV
regulations for individual case safety and periodic reporting.
Contribute as a key DSI contact for PV service providers to
address, escalate issues requiring attention or resolution, and
proactively drive operational excellence and continuous
improvement. Manage DSI's Strategic PV Partnerships and contracts
including vendor outsourcing agreements, PV Agreements (PVAs) and
Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI
contracts that are PV relevant and AE reporting language in
associated contractual templates. Ensures Good Pharmacovigilance
Practice and regulatory compliance in such arrangements. Contribute
to the management of PV Regulatory Intelligence (PVRI) and
dissemination across CSPV stakeholders for impact assessment.
Participates in the review and management of monthly, quarterly,
and ad hoc PVRI reports received from CSPV vendors.
Responsibilities: Strategic Partner Management: Manage Local/Global
PV service providers responsible for Call Center, individual safety
case processing, and aggregate reporting. Establish and maintain
collaborative relationships with key stakeholders within CSPV and
external functions including Clinical Development, Research
Development, Regulatory Affairs. Facilitate operational meetings
with CROs, License Partners, and PV vendors. Assist with PV
oversight of the DSI Call Center. Manage oversight of ICSR
processing activities including, Safety Information submission to
Health Authorities and License Partners, Reconciliation with
License Partners, Patient Support Programs, Market Research
vendors, Global Quality Supply Chain, Medical Information Social
Media and other suppliers. Ensure adequate training of resources to
enable quality of deliverables. Manage quality, efficiency, and
resources for PV service providers/vendors. Measure and monitor
performance of vendors against service level and KPIs. Manage the
development of governance, business continuity, quality, and vendor
monitoring plans. Maintain oversight for capability development of
service provider and resources. Plan, allocate, and utilize
resources and prioritize assignments. Contribute to management and
escalation of issues for resolution. Coordinate vendor assessments
and make recommendations on vendor partners. Manage the
coordination of PV participation in due diligence for acquisitions
and divestments. Assist with negotiation and transfer of PV
Business in case of Product Divestment. Collaborate with DSI audit
groups to ensure comprehensive auditing of Business Partners as
required to assure compliance with PV agreements. Participate in
audit and inspection readiness activities. Provide input for re
mediating PV system deficiencies cited in audit/inspections. Manage
the implementation of effective corrective and preventative action
PV Agreements and Contracts: Manages PVAs/SDEAs and maintains
oversight of PV relevant contracts. Contribute to overseeing and
setting standards for PV contract management. Review contributes to
revision of DSI contracts under negotiation (e.g. development,
license, distribution agreements)Manage, negotiate, revise document
collaborative license partner safety agreements with counterparts
from (license) partner companies. Participate in the development
and maintenance of a PVA repository. Contribute to the development
of standard processes and contract templates in cooperation with
Legal Department and PV functions. Assist in the development of
standards for information exchange with partners in cooperation
with PV functions. Initiate the implementation of obligations
deriving from these contracts. Organize and conduct periodic review
of contract quality and adherence PV Regulatory Intelligence:
Contribute to the management of PV Regulatory Intelligence and
dissemination across CSPV stakeholders for impact assessment.
Participates in the review and management of monthly, quarterly,
and ad hoc PV regulatory intelligence reports received from CSPV
vendors. Management Strategy and Goals: Assist CSPV Leadership in
developing PV goals, continued compliance, and strategy for process
improvement initiatives. Qualifications: Successful candidates will
be able to meet the qualifications below with or without a
reasonable accommodation. Education: Bachelor's Degree Nursing,
Pharmacy, Life Sciences, Health Care or related field required
Master's Degree Life Sciences preferred PharmD Life Sciences
preferred Experience: Minimum of 3 years of management experience
in PV preferred Minimum of 5 years of Drug Safety/Pharmacovigilance
experience, including both investigational and marketed products;
required 4 or More Years Knowledge of Good Clinical Procedures
(GCP) and Good Pharmacovigilance Procedures (GVP) required 4 or
More Years Knowledge of FDA regulations, clinical and safety
databases; preferred 4 or More Years Familiarity with Good Clinical
Procedures (GCP) and Good Pharmacovigilance Procedures (GVP),
PharmD, RN, or master’s degree in life sciences preferred Daiichi
Sankyo, Inc. is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment
without regard to sex, gender identity, sexual orientation, race,
color, religion, national origin, disability, protected veteran
status, age, or any other characteristic protected by law. Salary
Range: $124,960.00 - $187,440.00 Download Our Benefits Summary
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Keywords: Daiichi Sankyo, West Orange , Manager, PV Strategic Partner Management, Science, Research & Development , Basking Ridge, New Jersey
