Job Description
Job Details
Title: Associate, Pharmacovigilance ( Local Safety Officer)
Function: Medical Affairs & Pharmacovigilance
Department: Pharmacovigilance
Location: Muscat, Oman
1. JOB PURPOSE:
To monitor Hikma products' safety in order to perform various Pharmacovigilance tasks in support of Hikma products.
2. KEY ACCOUNTABILITIES:
Policies, Processes & Procedures
- Follows all relevant Department policies, processes, standard operating procedures, and instructions so that work is carried out in a controlled and consistent manner.
Day- to-day operations
- Follows the day-to-day operations related to own job to ensure continuity of work
Job Specific Accountabilities
- Monitors regulations & guidelines to detect PV updates.
- Assists in the performance of PV activities, including but not limited to, case processing, literature screening, aggregate reporting, risk management, signal management, safety variations, & safety agreements, to ensure compliance with procedural & regulatory requirements.
- Prepares PV documents, including but not limited to, aggregate reports, risk management plans, signal detection reports, safety variations, & safety agreements to ensure submission within the required timelines.
- Aids in the updates of the global product database to ensure it contains reliable & up to date product information
Continuous Improvement
- Contributes to the identification of opportunities for continuous improvement of systems, processes and practices considering industry best practices, improvement of business processes, cost reduction and productivity improvement.
Reporting
- Assists in the preparation of timely and accurate reports to meet company and Department requirements, policies, and standards.
Safety, Quality & Environment
- Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment.
Related Assignments
- Performs other related duties or assignments as directed.
3. QUALIFICATIONS, EXPERIENCE, & SKILLS:
- Bachelor’s degree in pharmacy.
- Omani National is a must.
- 0-3 years' of experience in PV or any other relevant field.
- Valid Omani Driving license.
