Senior PV Operations Scientist - Permanent Position
Posted 10 days 15 hours ago by Eisai Europe Limited
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) PV's 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,
- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- 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.
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.
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