Adverse Event Reporting Specialist
We are seeking a detail-oriented professional to serve as the liaison between business users, regulatory teams, and IT in ensuring accurate and compliant adverse event reporting.
This critical role is responsible for maintaining patient safety, regulatory compliance, and efficient safety operations across multiple teams.
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Collaborate with stakeholders to implement or enhance safety systems, providing support during validation and user acceptance testing.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Evaluate compliance with global regulatory standards such as FDA, EMA, and MHRA.
* Provide training to end-users on safety systems and processes.
Responsibilities:
* Analyze data related to adverse events and pharmaceutical products.
* Develop, implement, and maintain Pharmacovigilance Systems (PVS).
* Work closely with cross-functional teams including Regulatory Affairs, Clinical Operations, and IT.
* Ensure compliance with regulations and standards like ISO 14155:2011 and ICH-GCP.
* Stay updated on regulatory changes and updates.
Requirements:
* Bachelor's degree in Life Sciences, Pharmacy, or IT.
* 3+ years of experience working with pharmacovigilance systems.
* Experience with Argus, ArisG, and Veeva Vault Safety software.
* Knowledge of ICH-GCP, ISO 14155:2011, and other relevant regulations.
Preferred skills:
* Certification in pharmacovigilance.
* Proficiency in MS Office, Excel, Access, and PowerPoint.
* Familiarity with Veeva Vault Rave and other CRM systems.