Title:  Trainee, Pharmacovigilance

1. JOB DETAILS:

Title:

Trainee, Pharmacovigilance

Function

Medical Affairs & Pharmacovigilance

Department

Pharmacovigilance

2. JOB PURPOSE:

This role is responsible for monitoring the safety of Hikma products and performing pharmacovigilance related tasks in support of Hikma products.

3. KEY ACCOUNTABILITIES:

Description

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 pharmacovigilance regulations and guidelines to be aware of updates.
• Assists in the performance of pharmacovigilance process activities, i.e., case processing, literature screening, aggregate reporting, risk management, signal management, safety variations, safety agreements, to ensure these are performed in compliance with regulations and guidelines, with high quality and within the required timelines.
• Assists in the preparation of pharmacovigilance documents, i.e., aggregate reports, risk management plans, signal detection reports, safety variations, safety agreements.
• Follows-up on regulatory submission/distribution to local health authorities and archiving of all safety reports to ensure that health authorities requirements are fulfilled within the defined timelines.
• Aids in the updates of the global product database to ensure it serves as a reliable and up to date source for 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.

4. QUALIFICATIONS, EXPERIENCE, & SKILLS:

Minimum Qualifications:

MD or PharmD or PharmB or equivalent degree in Life Sciences.

Minimum Experience:

0-3 years of relevant pharmaceutical experience.