Pharmacovigilance Operations Lead (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

 

Pharmacovigilance Operations Lead (m/f/x)

 

The position:

Leads the Pharmacovigilance (PV) Operations team at Daichi Sankyo Europe which focuses on individual case safety report (ICSR) handling from post-marketing. PV Operations includes all aspects of case processing in the safety database, ensuring the AE collection process (i.e. Spontaneous, Solicited, Post-Marketing Study sources), regulatory reporting requirements, vendor management for case processing and its quality and compliance.
 

The position is closely working with the global PV operations team (US, Japan) and global case processing vendors and act as primary contact among CSPV and other functions for PV operational activities and assists in management of PV audit/inspection.
 

Contributes to the global PV Operations strategy and decision making via the global PV operations team.

The position reports to the Head of the DSE CSPV department (EU-QPPV) as well as the Global PV operations Lead.

 

Roles and Responsibilities:

ICSR handling

  • Oversees the system for ICSR collection, processing, reconciliation and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met. This includes AE report intake, Case processing, Follow-up requests, ICSR reporting, ICSR quality control, SAE reconciliation, Partner reconciliation, Case processing vendor management, Workflow management.

  • Ensures that all safety reports received are processed and reported according to regulatory requirements and company procedures. Supports and/or provides internal training on ICSR activities as applicable.

  • Prepares and maintains company procedures around case management activities and assists in management of PV audit/inspections.

 

Case processing CRO management

  • Manages, communicates and provides trainings on ICSR activities, safety procedures and processes on a regular basis with case process service providers and oversees their quality of work.
  • Develops and monitors case processing KPIs/metrics, and takes appropriate actions with the case process service providers to achieve continuous improvement.


Study start up

  • Oversees and works with clinical study teams, develops and maintains study-specific SAE Flow Plans/Safety Management Plans along with Product Safety Physicians to ensure all required safety information to be collected following the regulations and medical requirements. Facilitates and ensures communication with functions involved with receiving, investigating, or reporting AEs; supports cross-functional study and program teams. Develops SAE Reconciliation Plan and oversees the reconciliation process.

  • Reviews study documents on behalf of PV Operations team (Protocol, Data Management Plan, PV Agreements/Safety Data Exchange Agreements), supports setting up electronic data capture (EDC) systems for AE collection and reporting process to the Health Authorities, Affiliates and Partners (e.g. Configuration of reporting rules in the safety database).
     

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, PhD preferred
  • Minimum 8 years of experience in PV with an advanced degree; 10 years of experience with bachelor’s degree 
  • Leadership skills, Positive attitude
  • Strong PV regulation knowledge 
  • Knowledge of international and European PV laws
  • Experience in case management
  • 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.