Job Description
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 to 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 remote and is based in Bangalore, India. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
**Purpose and Scope:**
This role is accountable for accurate and timely execution, distribution and maintenance of all Astellas Pharmacovigilance Agreements (PVAs) with Business Partners including, but not limited to, safety data exchange agreements and Good Pharmacovigilance Practice (GVP) agreements to ensure compliance with worldwide regulatory requirements and Astellas policies. This role contributes to the development and successful implementation of the Business Partner Management (BPM) 1 -3-year strategic plan. The incumbent is the main point of contact for Astellas business development both within headquarters and in the affiliates and is responsible for establishing and maintain good business relations with Astellas' business partners. The timely execution and implementation have a direct impact on Astellas compliance
**Responsibilities and Accountabilities:**
**Within GPV/Affiliates:**
+ Identify, develop, negotiate, and finalize (or terminate) complex PV Agreements with all relevant business partners in a timely fashion; ensure timely re-negotiation, updating and finalization (or termination) of complex PV Agreements according to Astellas procedures or change in requirements
+ Create/Maintain Agreements with Astellas Affiliates
+ Act as liaison to PV functions (PVP, GSS, GMS, Affiliate Management, and QMS) to assess feasibility of proposals from business partners resulting from license agreements, acquisitions, divestitures, or collaborations to ensure ability to comply with obligations as stated in the agreement; distribute finalized PV Agreements with GPV functions to allow compliance to obligations.
+ Ensure accurate information is available for GPV, affiliates and other relevant functions during PVA development.
+ Support QMS in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to GBPM
+ Ensure accurate information is maintained in the tracking tools for PVAs
+ Ensure adequate local and global procedures are available and adhered to for PVA development and maintenance; Maintain templates and procedures in line with regulations and Astellas policies
+ Support the supervisor in Training and mentoring new staff/contractors and other departments ensuring the relevant safety staff have all necessary knowledge and expertise to execute their responsibilities
+ Escalate issues appropriately
+ Maintains an up-to-date knowledge of PV regulations and guidelines.
+ Support PV contract language for suppliers who may
+ Within Astellas
+ Manage relationships with key stakeholders outside of GPV (CRQA, Business Development, Legal, etc.) to enable timely identification of commercial agreements requiring PVA development and promote compliance to corporate safety standards; may include conducting due diligence
+ Liaise with CRQA regarding audit strategy for business partners
+ With Business Partner
+ Manage relationships with business partners
+ Act as liaison with business partner for compliance investigations, audits or inspections
**Requirements**
**Accountability:**
Accountable for negotiating, finalizing and maintaining PVAs on behalf of the GPV organization in a timely manner to ensure compliance with regulations. Implementation of PVAs has a significant impact on Astellas' compliance with regulatory requirements and relationships with Business partners therefore the risk of this position is high. Non-compliance may have a significant impact on financial budget.
**Quantitative Dimensions:**
+ May have responsibility for assigning tasks/work to other team members.
+ Maintenance of approximately 75-100 PVA
+ Primary point of contact for 25-50 business partners
+ Failure to meet contractual obligations can have financial consequences for Astellas
**Organizational Context:**
+ This position reports Sr. Director Business Partner, Management
+ Peers include BPM team located across the globe
+ This role has critical and frequent interactions with senior management from business partners, Astellas' business development, legal, EU QPPV, JP QPPV, CQA, affiliate DSOs, Affiliate general managers
**Required Qualifications:**
+ Minimum BA/BS degree. 6+ years’ experience in the pharmaceutical industry with at least 6 years in Pharmacovigilance
+ Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU, FDA, PMDA and local regulations.
+ Excellent proficiency in English language including speaking and writing.
+ Strong understanding of contract language and legal terminology, with ability to generate and interpret complex contract language.
+ Strong negotiation and communication skills for effective interactions with Business Partners
+ Understanding of contact compliance and regulatory requirements specific to pharmacovigilance.
**Working Environment:**
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility
**Astellas’ Global Capability Centres – Overview**
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
_"Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help"_
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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 remote and is based in Bangalore, India. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
**Purpose and Scope:**
This role is accountable for accurate and timely execution, distribution and maintenance of all Astellas Pharmacovigilance Agreements (PVAs) with Business Partners including, but not limited to, safety data exchange agreements and Good Pharmacovigilance Practice (GVP) agreements to ensure compliance with worldwide regulatory requirements and Astellas policies. This role contributes to the development and successful implementation of the Business Partner Management (BPM) 1 -3-year strategic plan. The incumbent is the main point of contact for Astellas business development both within headquarters and in the affiliates and is responsible for establishing and maintain good business relations with Astellas' business partners. The timely execution and implementation have a direct impact on Astellas compliance
**Responsibilities and Accountabilities:**
**Within GPV/Affiliates:**
+ Identify, develop, negotiate, and finalize (or terminate) complex PV Agreements with all relevant business partners in a timely fashion; ensure timely re-negotiation, updating and finalization (or termination) of complex PV Agreements according to Astellas procedures or change in requirements
+ Create/Maintain Agreements with Astellas Affiliates
+ Act as liaison to PV functions (PVP, GSS, GMS, Affiliate Management, and QMS) to assess feasibility of proposals from business partners resulting from license agreements, acquisitions, divestitures, or collaborations to ensure ability to comply with obligations as stated in the agreement; distribute finalized PV Agreements with GPV functions to allow compliance to obligations.
+ Ensure accurate information is available for GPV, affiliates and other relevant functions during PVA development.
+ Support QMS in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to GBPM
+ Ensure accurate information is maintained in the tracking tools for PVAs
+ Ensure adequate local and global procedures are available and adhered to for PVA development and maintenance; Maintain templates and procedures in line with regulations and Astellas policies
+ Support the supervisor in Training and mentoring new staff/contractors and other departments ensuring the relevant safety staff have all necessary knowledge and expertise to execute their responsibilities
+ Escalate issues appropriately
+ Maintains an up-to-date knowledge of PV regulations and guidelines.
+ Support PV contract language for suppliers who may
+ Within Astellas
+ Manage relationships with key stakeholders outside of GPV (CRQA, Business Development, Legal, etc.) to enable timely identification of commercial agreements requiring PVA development and promote compliance to corporate safety standards; may include conducting due diligence
+ Liaise with CRQA regarding audit strategy for business partners
+ With Business Partner
+ Manage relationships with business partners
+ Act as liaison with business partner for compliance investigations, audits or inspections
**Requirements**
**Accountability:**
Accountable for negotiating, finalizing and maintaining PVAs on behalf of the GPV organization in a timely manner to ensure compliance with regulations. Implementation of PVAs has a significant impact on Astellas' compliance with regulatory requirements and relationships with Business partners therefore the risk of this position is high. Non-compliance may have a significant impact on financial budget.
**Quantitative Dimensions:**
+ May have responsibility for assigning tasks/work to other team members.
+ Maintenance of approximately 75-100 PVA
+ Primary point of contact for 25-50 business partners
+ Failure to meet contractual obligations can have financial consequences for Astellas
**Organizational Context:**
+ This position reports Sr. Director Business Partner, Management
+ Peers include BPM team located across the globe
+ This role has critical and frequent interactions with senior management from business partners, Astellas' business development, legal, EU QPPV, JP QPPV, CQA, affiliate DSOs, Affiliate general managers
**Required Qualifications:**
+ Minimum BA/BS degree. 6+ years’ experience in the pharmaceutical industry with at least 6 years in Pharmacovigilance
+ Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU, FDA, PMDA and local regulations.
+ Excellent proficiency in English language including speaking and writing.
+ Strong understanding of contract language and legal terminology, with ability to generate and interpret complex contract language.
+ Strong negotiation and communication skills for effective interactions with Business Partners
+ Understanding of contact compliance and regulatory requirements specific to pharmacovigilance.
**Working Environment:**
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility
**Astellas’ Global Capability Centres – Overview**
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
_"Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help"_
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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