Passion for Innovation. Compassion for Patients.
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products.
In Europe, we focus on two areas : In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat;
in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information : .
For our headquarter in Munich we are seeking highly qualified candidates to fill the position
Pharmacovigilance (PV) Partner & Affiliate Manager (m / f / x)
Purpose of the function :
This position will work with PV Partner & Affiliate Management Lead and be responsible for PV Partner and EU Affiliate Management activities within the Clincial Safety and Pharmacovigilance (CSPV) department.
This includes PV relevant contract management (i.e. PV agreements / Safety Data Exchange Agreements (SDEAs) with PV partners / EU affiliates, service agreements with PV vendors) and performance oversights to ensure all required PV systems are implemented and operating appropriately among the parties.
In addition, this function will lead process improvement initiatives and enhancement of standards across EU affiliates.
This position will also work with global team (e.g. US, Japan) and involve in the global discussion with strong knowledge of EU PV system to enhance DS global standards on partner / affiliate management.
This position will report to PV Partner & Affiliate Management Lead and is expected to work independently while providing solutions / best practices and executes strategy to achieve proactive and continuous process enhancement.
Roles and Responsibilities :
EU Affiliate management activities
Be responsible for the oversight of Local Safety Officers (LSOs) across EU countries and ensure all quality of work and the compliance to regulations / legislation
Provide strategic oversight and ensure consistency between global and local PV processes
Facilitate the local implementation of global processes (e.g. management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements)
Directs and oversees (including regular visits and meetings with) local personnel and LSOs to ensure the PV requirements and compliance in the respective countries and PV personnel is adequately trained
Provide leadership and support to EU affiliate members prior to and during PV audits and inspections
Contract management activities
Implement / maintain PV agreements / SDEAs with partners / EU affiliates / PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered in the contract.
Maintain contract template as current
Coordinate periodic communications with partners and ensure the contract is up-to-date and the process is operating well
Organise trackers with the list of the contract and required commitments in each contract to ensure all required activities defined in the contract is performed appropriately
PV regulatory intelligence
Be a primary function for the oversight of PV regulatory intelligence in European countries working together with EU affiliate LSOs and global counterparts
Work with SMEs, perform impact analysis of the regulation changes, implement the required process changes and document the actions taken as appropriate
Maintain / enhance processes for PV regulatory intelligence monitoring
Professional experience and personal skills :
Bachelor’s degree at minimum required; 6-9 years of experience with an advanced degree; 8-11 years of experience with a bachelor’s degree
Master degree in Life Sciences, Pharmacy or Medical Sciences preferred
Possesses strong knowledge of international and European PV laws and guidances
Good or excellent written and verbal communication skills in English
Analytic and systematic approach with good problem solving skills
Demonstrates effectiveness in working in a multidisciplinary and matrixed environment
Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
Ability to understand complex matters with a continuous focus on improvement
Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
Flexible and adaptable
What we offer
Working at Daiichi Sankyo
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs.
We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches.
Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow.
When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.