Senior PV Operations Scientist - Permanent Position (4141)
The Company
Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology Neurology and Pain therapy areas.
By joining Eisai you will be working for an organisation with a human healthcare philosophy which means that we put the patient first in everything we do.
Your new role
The Senior PV Operations Scientist is responsible for the PV Alliance Management process for the Eisai EMEA region. The Senior PV Operations Scientist also supports leads and partakes in Eisai Business initiated projects and other ad hoc activities where required.
Act as EEL (Eisai Europe Ltd) PVs primary liaison with assigned third parties (e.g. distributors) and internal stakeholders
Ensure all EEL managed Safety Data Exchange Agreements (SDEAs) are prepared reviewed and revised as required in line with corporate and regional controlled documents (CDs) and/or changes in requirements and that the SDEA repository and associated documentation is maintained
Ensure the relevant internal stakeholders are informed of the new or revised final SDEAs and where applicable assist in the implementation
Develop and implement effective processes to monitor and ensure compliance with third party PV agreements
Provide support for the Regional Safety Office as required including during audit/inspection preparations and ad hoc support with ICSR case processing activities
Provide support for QPPV office by contributing relevant information for the update of the PV System Master File (PSMF)
Author relevant controlled documents relating to job role/responsibilities
Perform other ad hoc tasks as assigned by manager
What are we looking for
Proven relevant experience in a Pharmacovigilance role
Prior experience with SDEAs and building relationships with PV partners
In depth knowledge of Pharmacovigilance regulatory reporting requirements in European countries
Graduate level education preferred (life sciences pharmacy or nursing degree would be an advantage)
What we offer in return
Eisai offers a competitive salary and excellent wider benefits package that includes
Hybrid working
Electric charging points for Electric/Hybrid vehicles
Discretionary Bonus
Free onsite parking
Subsidised onsite restaurant and coffee shop
Learning and development opportunities
Retail discounts
Well-being & mental health awareness programmes
Multi-faith prayer room
You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility which is our EU Headquarters and offers an inclusive and collaborative working environment.
What you need to do next
If you are interested in this position please click apply now at the top of this advert. Upon submitting your application you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application. If you have any questions please contact us on
Eisai Recruitment Statement
Diverse perspectives and experiences are critical to our success and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.
Eisai EMEA EDI Commitment Statement
We believe that diverse and inclusive teams promote wellbeing learning and innovation helping Eisai serve our patients their families our employees and society. Our commitment is:
to embrace and celebrate our differences respecting and valuing each other.
to include equity diversity and inclusion practices in all that we do so everyone has a full sense of belonging.
to value individual talent where every employee can be themselves and thrive in an environment of openness trust and integrity
Required Experience:
Senior IC
Senior PV Operations Scientist - Permanent Position (4141) The CompanyEisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology Neurology and Pain therapy areas.By joining Eisai you will be working for an organisation with a human healthcare philos...
Senior PV Operations Scientist - Permanent Position (4141)
The Company
Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology Neurology and Pain therapy areas.
By joining Eisai you will be working for an organisation with a human healthcare philosophy which means that we put the patient first in everything we do.
Your new role
The Senior PV Operations Scientist is responsible for the PV Alliance Management process for the Eisai EMEA region. The Senior PV Operations Scientist also supports leads and partakes in Eisai Business initiated projects and other ad hoc activities where required.
Act as EEL (Eisai Europe Ltd) PVs primary liaison with assigned third parties (e.g. distributors) and internal stakeholders
Ensure all EEL managed Safety Data Exchange Agreements (SDEAs) are prepared reviewed and revised as required in line with corporate and regional controlled documents (CDs) and/or changes in requirements and that the SDEA repository and associated documentation is maintained
Ensure the relevant internal stakeholders are informed of the new or revised final SDEAs and where applicable assist in the implementation
Develop and implement effective processes to monitor and ensure compliance with third party PV agreements
Provide support for the Regional Safety Office as required including during audit/inspection preparations and ad hoc support with ICSR case processing activities
Provide support for QPPV office by contributing relevant information for the update of the PV System Master File (PSMF)
Author relevant controlled documents relating to job role/responsibilities
Perform other ad hoc tasks as assigned by manager
What are we looking for
Proven relevant experience in a Pharmacovigilance role
Prior experience with SDEAs and building relationships with PV partners
In depth knowledge of Pharmacovigilance regulatory reporting requirements in European countries
Graduate level education preferred (life sciences pharmacy or nursing degree would be an advantage)
What we offer in return
Eisai offers a competitive salary and excellent wider benefits package that includes
Hybrid working
Electric charging points for Electric/Hybrid vehicles
Discretionary Bonus
Free onsite parking
Subsidised onsite restaurant and coffee shop
Learning and development opportunities
Retail discounts
Well-being & mental health awareness programmes
Multi-faith prayer room
You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility which is our EU Headquarters and offers an inclusive and collaborative working environment.
What you need to do next
If you are interested in this position please click apply now at the top of this advert. Upon submitting your application you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application. If you have any questions please contact us on
Eisai Recruitment Statement
Diverse perspectives and experiences are critical to our success and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.
Eisai EMEA EDI Commitment Statement
We believe that diverse and inclusive teams promote wellbeing learning and innovation helping Eisai serve our patients their families our employees and society. Our commitment is:
to embrace and celebrate our differences respecting and valuing each other.
to include equity diversity and inclusion practices in all that we do so everyone has a full sense of belonging.
to value individual talent where every employee can be themselves and thrive in an environment of openness trust and integrity