Pharmacovigilance Associate - KSA - Riyadh

Role Purpose:

The Pharmacovigilance Associate will support all PV activities for Saudi Arabia. ensure the integrity of the pharmacovigilance system in accordance with the Good Pharmacovigilance Practices (GVP) for Arab countries, SFDA regulations and EU-GVP and to coordinate with different stakeholders and business partners to maintain it.

Responsibilities (what must be done):

• Receive and process ICSR reports originated from different healthcare sources via Argus and conduct follow-up activities to obtain necessary additional information for case processing.
• Handle ICSR reconciliation for the Saudi market and communicate monthly activities with all distributors and the global PV team.
• Prepare PV training plans for the Saudi team and ensure PV training is conducted annually and for new joiners. Assist in collecting the necessary documentation (CV, Job description, Training plans, and training records) and storing it.
• Feed PV trackers and maintain it up to date without delay and ensure data accuracy into pharmacovigilance database systems and trackers
• Create, review and update safety data exchange agreements where needed
• Contribute to the development, review and update of the necessary SOPs for all local PV activities
• Review, update and maintain local PSSF.
• Ensure PV inspection readiness for all SFDA audits, coordinate and follow up with Health Authorities inspectors and ensure the agreed CAPA is finalized on timely manner
• Participate in internal and external audits related to pharmacovigilance activities in KSA and on regional level.
• Responsible for PSUR/ PBRER submission as per the submission plan and in compliance with deadline.
• Support PV compliance reporting on monthly and quarterly periods to regional and global teams
• Act as local QPPV and be available to Support local authority requests on 24x7 basis
• Act in compliance with the internal SOP and ways of working
• Annotation and review of the artworks in compliance with SFDA. Artwork release when any approval is received and ensures all relevant stakeholders are informed
• Responsible for SDI system update in a timely manner
• Coordinate with global PV team to ensure availability of the updated documents related to product’s safety updates/ CCDS updates and share it with regulatory team for submission.
• Ensure that local safety signals raised by SFDA are addressed within requested timelines.

Position Requirements:

Bachelor Degree

2- 3 years work experience in PV within a pharmaceutical company

Technical Skills:

Local and regional PV Guidelines - To be able to implement and comply

Familiar with ARGUS software

Aspen Competencies:

BUSINESS:

• Performance Driven
• Accountability/ownership

PEOPLE:

• Dealing with Ambiguity, Embrace Change
• Communicate effectively

SELF:

• Continuously Grow and Develop
• Take Action with Integrity