Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Pharmacovigilance, Epidemiology & Risk Management.

Responsibilities

• Provision of pharmaceutical expertise in the entire field of pharmacovigilance. 

• Case Management 

• Knowledge and oversight of the entire ICSR process from intake to reporting, how this process impacts other services in SCS (aggregated reports, compliance, signalling, etc) and provide guidance to applicable teams performing these tasks. 

• Oversight of team PV activities including ICSR reporting, reconciliations, follow up requirements, literature screening, signalling, inquiry and complaint management. 

• Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects. 

• Review and approve safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports) DSURs (Development Safety Update Reports), risk management plans and signal detection reports required and in support of risk-benefit profiling. 

• Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects. 

• Organize and perform training of the above-mentioned procedural documents. 

• Preparation of and participation in internal and external PV audits/inspections. 

• CAPA review and approval. 

• PSMF maintenance 

• Program Management Support 

• Review of PV Intelligence Reports and perform gap analysis/impact assessment on own processes. 

• Training of staff in selected areas of pharmacovigilance and client specific activities and requirements. 

• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required. 

Education and Work Experience

• Bachelors degree in Life Science

• Several years’ experience and profound knowledge in the field of pharmacovigilance 

• Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance

Skills, Knowledge and Ability Requirements

• Demonstrable ability in leading, mentoring, managing and motivation of staff.

• Ability to lead project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones.

• Ability to manage internal and external (client) relationships on level of client's department heads; ability to discuss and align mid-term goals of collaboration.

• Very good communication skills (written and verbally); proven capability to communicate critical issues and propose appropriate (cross-divisional) solutions to decision makers. Good presentation skills.

• English business fluent & local language (as appropriate).

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a