Senior PV Operations Scientist - Permanent Position

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) 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, 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 [email protected] 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