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Astellas Pharma US PV Interface Manager in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

  • Responsible for development and maintenance of excellence in Regional PV Process ICSR Management Interface.

  • Reports to the Lead Regional PV Process ICSR Management Interface and contributes to the successful execution of the GPV objectives and 1-3 year operational plan, supporting the overall GPV mission.

  • This function is the key contact for routine interactions with License Partners regarding operational activities described in safety data exchange agreements (SDEAs), as well as for Astellas-internal functions requiring regular interactions with PV Process.

  • Responsible for regulatory compliance of regional (outsourced) activities. Works extensively with PV process staff within the region as well as with regional or assigned global license partners and Astellas Global Development Organization, Medical Affairs and local Drug Safety Officers to ensure alignment with GPV's vision and that these interactions directly support the ongoing assurance of the safety profile of Astellas products.

Essential Job Responsibilities:

The ICSR Management Liaison Manager is responsible for:

ICSR Processing:

  • Ensure PV requirements are incorporated in protocol design for interventional as well as non-interventional studies and Market Research Programs and/or Safety Management Plans for clinical studies or organized data collection programs conducted in (assigned) region

  • Build and maintain close relationships with DSOs, Regulatory Affairs, Clinical and Medical Affairs functions in assigned region

Product Quality Complaint Management:

  • Build and maintain close relationships with QA, Regulatory Affairs, Product Supply and Manufacturing functions in assigned region

  • Responsible for operational execution of Product Quality Complaint processing and evaluation in assigned region (Triage, Forwarding, Investigation, Reconciliation and Reporting)

Quality, Data Assurance & Business Information management

  • Represents Regional PV Process in Inspections, PV audits and non-PV audits (GCP) as requested.

  • Oversee Regulatory compliance and QC of outsourced activities and implement business regulatory compliance and inspection readiness requirements in cooperation with regional PV Process assigned license partners

Vendor & Partner Management:

  • Supports operational vendor management of regional vendors to maximize the quality, compliance and (cost) effectiveness of the work team outputs.

  • Manage periodic interactions with License Partner(s) according to the SDEA(s) as required for Operational activities that are either delegated to the License Partner or performed by Astellas (or its vendor(s)) on behalf of the License Partner

  • Build and maintain collaborative relationships with regional or assigned global license or co-developmental partners and vendors. Contribute to joint development of strategies to continuously improve deliverable quality.

  • Serve as liaison between the regional PV Process organization and other Astellas functions, License Partners and the vendor(s)

  • Oversees the compliance of License Partner-related activities and ensures Corrective and Action Preventive Actions (CAPAs) are implemented in case of non-compliance.

  • Responsible for timely escalation in case of compliance issues.

  • Ensure adherence to regional regulatory obligations and alignment with global processes in tight cooperation with the Business Partner Maintenance team

  • Involved in ensuring regional vendor compliance to contract terms.

Budget

  • Ensures major projects are completed as scheduled, within budget and with high quality. Ability to identify and initiate process improvements. Assignments and projects are often self -initiated. Interprets, executes and recommends changes to established policies and programs. Failure to achievement results could result in a failure to achieve organizational objectives.

People & Organization Management

  • Deputizes for the team leader as needed.

  • Responsible for the development and maintenance of effective collaborations with peers in Global PV Process Vendor Management and internal GPV key stakeholders and functions.

  • Supports the execution of the GPV operational strategy, supporting the overall GPV mission.

  • Works extensively with relevant internal and external stakeholders, particularly with Business Partner Management for license partner communication and SDEA contents.

Quantitative Dimensions:

  • Supports Regulatory inspection management activities and may serve as Inspection SME in explaining regional interactions.

  • These activities have major significance to the GPV organization and the company at large and require in-depth subject matter expertise and excellent communication skills to effectively manage complex operations resulting in regulatory controlled deliverables with external partners.

  • The team interacts with up to 100 regionally assigned license partners (different depending on region).

  • Individually responsible for management of operational aspects of 5-10 License Partners requiring frequent interactions.

Organizational Context:

  • Reporting to the Lead Regional PV Process ICSR Management Interface within the regional PV Process organization. Peers include colleagues in the other regions and counterparts at business partners.

  • May deputize for the Regional PV Process ICSR Management Interface Lead in the assigned region.

  • Cooperate closely with Astellas' QPPV Office, as regionally applicable, the regional Quality Organization, Product Supply & Manufacturing, Medical Affairs, regional representatives of the Global Development Organization, as well as the PRPs in GMS/GSS on product-specific matters.

Qualifications:

Required

  • Minimum BA/BS in life sciences

  • Minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development

  • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations

  • In-depth knowledge and understanding of PV Process regulatory requirements and guidelines in assigned region

  • Proven experience with (GxP) Qualities Management System.

  • In-depth understanding of PV, data management and adverse event reporting and processing.

Skills and competencies:

  • Demonstrates effective leadership to ensure interactions and compliance are maintained at highest standards at all times

  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.

  • Demonstrated ability to proactively predict and resolve complex problems and/or conflict situations, think strategically and tactically, generate solutions to complex problems and build consensus in interaction with other functions within or outside the Astellas organization. Able to generate insights and leverage learnings at the individual and team level.

  • In-depth knowledge of pharmacovigilance processes and operations, including outsourcing and vendor management.

  • Experience with global responsibilities for safety projects

  • Able to lead meetings, present orally and interact with external bodies

  • Excellent communication and presentation skills in English (written and spoken)

  • Ability to leverage all available resources internally and externally

  • Able and willing to travel as required

  • Able to determine best course of action based on strategic direction

  • Decision making skills

  • Negotiation skills

  • Independent working -- plans, schedules and arranges own activities to achieve desired results

  • Independently manages projects that span across various functions or departments

  • Consults with senior management on a regular basis.

  • Has a strong sense of urgency and compliance.

Preferred

  • Previous relevant experience in CROs and/or other pharma companies

  • Demonstrated experience in cooperation with license partners

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

#LI-SS

Category Pharmacovigilance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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