Lead of Pharmacovigilance Database Management & Analytics (m/f/x)

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Date: 16-Nov-2021

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

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: www.daiichi-sankyo.eu.

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position

 

Lead of Pharmacovigilance Database Management & Analytics (m/f/x)

 

The position:

Leads the Pharmacovigilance Database Management and Analytics team at Daichi Sankyo Europe which is responsible for the oversight and management of the Global Safety Database and Data Analytic tools (e.g. PV reporting and analytic solutions) to meet industry standards and ensures these are appropriately configured to comply with Health Authority requirements globally including system validation, configuration and training activities.


This team is also responsible for data analytics and generation of pharmacovigilance reports as well as supporting interfaces for appropriate data exchange (e.g. sharepoint, box).
 

The position is closely working with global teams (US, Japan) and system support vendors and is involved in the global strategy and decision making on PV system/technology related activities.
 

The position reports to the Head of the DSE CSPV department (EU-QPPV) locally as well as the PV DB Management and Analytics global function Lead.

 

Roles and Responsibilities:

Management of Global Safety Database and Data Analytic tool                  

  • Oversees all PV systems and involve in strategy dicussion on global PV system/technology related activities which includes new system installation, configuration and integration with different sytems.  
  • Identifies and develops new systems/databases to meet future business needs and expectations of Regulatory Authorities.
  • Ensures the system support vendors are qualified, high performing and motivated to achieve the business objectives.
  • Implements advenced technologies (e.g. E2b import, Axway configuration) and process automation for business process improvement.
  • Works with Medical, PV operation and Regulatory Intelligence teams and ensures that all safety database configurations are well-maintained. Manages reported issues on Systems including troubleshooting, liaising with IT Application Support team and helpdesk.
  • Ensures appropriate company procedures are in place for timely and accurate reporting of PV information for expedited, aggregate and ad-hoc reporting needs and assists in management of PV audit/inspections.
     

Data Analytics/PV reports

  • Ensures the team provides PV reports as per the request of the PV subject matter experts (e.g. Safety surveillance/Medical assessment, Health Authority & Partner requests, Periodic reports, KPIs/Metrics report, Audit/Inspection readiness/Reconciliation) in a regular, timely and automated manner.

  • Ensures availability of non-standard safety reports, which enable PV subject matter experts to find solutions with complex requirements/assessments.
     

People/Team Management

  • Leads, manages and mentors staff and assigns responsibilities as appropriate to maximize the team outputs and provides opportunities for individual growth.

  • Prepares individual development plans for the members within the function and supports the execution.

 

Professional experience and personal skills:

  • Bachelor’s degree at minimum required; Master, Ph. D preferred

  • Minimum 8 years of experience in PV with an advanced degree; 10 years of experience with a bachelor’s degree 

  • Experience with PV tools, handling Database structure and validation ( i.e. Oracle, Argus or ARISg) is required.

  • Knowledge around programing (e.g. SAS, SQL) is preferred

  • Leadership skill, Positive attitude, Customer focus

  • Possesses strong PV regulation knowledge 

  • Knowledge of International and European PV laws

  • Strong communication skills

  • Fluent business English (oral and written)

  • Relocation to Munich preferred

 

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.