Special Consulting Services Specialist - Pharmacovigilance, Epidemiology & Risk Management
AmerisourceBergenAbout the role
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
Assist with the Pharmacovigilance, Epidemiology & Risk Management operational tasks and all aspects of technical delivery and project management.
Responsibilities
Pharmacovigilance Team Support
Data entry and QC of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
Support in the generation, processing, documenting, and tracking of follow-up requests
Perform L2A and MLM for relevant clients
Screening and documentation of scientific global and local literature regarding safety relevant publications
Follow up calls to patients or health care professionals and documentation of calls within trackers or the safety database
Monitoring of incoming email for multiple programs
Regulatory submissions of Individual Case Safety Reports and /or to partners
Perform reconciliation with clients and applicable partners
Complete monthly/quarterly metrics and KPIs in excel spreadsheets
Support the Program Manager or Workstream Lead with all necessary information related to the specific project/program, as needed.
PSMF maintenance
Participate and help prepare for audits or inspection
Prepare deviations concerning SCS practice area
Assist with administrative tasks in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
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
Professional education or University degree in Life Science
Basic understanding/knowledge in the field of pharmacovigilance
Skills and Knowledge
Ability to prioritize and manage own time and tasks.
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.
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 variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora
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