Pharmacovigilance Analyst

The purpose of the role is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance (PhV) in aligned countries. In the absence of primary PhV role the PhV back-up shall take up key responsibilities described in this document.

1. General Responsibilities and Regulatory Compliance:
* Execute pharmacovigilance activities as nationally required (such as: adverse event management, expedited and periodic reporting
* Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
* Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.

2. Adverse event (AE) management responsibilities:
* Serve as point of contact for reception and collection of AE reports.
* Adverse event/device case entry into the safety database.
* Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, both for initial and follow-up reports.
* Responsible for the accuracy and completeness of information reported from clinical trial, post marketing study and spontaneous adverse events for marketed products and devices.
* Complete case follow-up as directed or required.
* Responsible for generating and submission of the necessary case reports that are required for expedited reporting to the MoH/RA.
* Reconciliate case reports with business partners, medical information, and product quality.
Archive case source documentation

3. Standards and Inspection Readiness:
* Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments
* Help to interpret relevant regulations and guidelines.
* Responsible for ensuring compliance with MoH/RA(s) requirements and GPS policies, procedures, and processes.