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.