Title:  Associate, Pharmacovigilance

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.