Associate, Pharmacovigilance

At Hikma we put better health within reach, every day in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more info Disclaimer: EMPLOYMENT RECRUITMENT FRAUD ALERT Please be advised that the Hikma Pharmaceuticals Group does not ask its employees or prospective employees to wire any money either to its bank accounts or to any third party, and does not conduct employment interviews via any social media platform, Google Hangouts, Yahoo! Messenger, text message, or e-mail. Unfortunately, employment scams are increasingly common and it is important to remain vigilant when conducting a job search. For more information about these scams, see the UK National Fraud Intelligence Bureau’s website and the US Better Business Bureau’s article on the subject. If you receive a request to send money through any means or a request for personal information from anyone claiming to be a Hikma recruiter, DO NOT REPLY. Instead, please forward the communication(s) to us at vacancy@hikma.com so that we may provide it to relevant law enforcement agencies, as appropriate.

Website

http://www.hikma.com Job Purpose:

To monitor Hikma products' safety in order to perform various Pharmacovigilance tasks in support of Hikma products.

Duties & Responsibilities

• Follows all relevant Department policies, processes, standard operating procedures, and instructions so that work is carried out in a controlled and consistent manner.
• Monitors regulations and guidelines to detect PV updates.
• Assists in the performance of PV activities in Egypt, including but not limited to, case processing, local literature searching, aggregate reporting, risk management, health risk assessment, product labeling reviews, and safety agreements, to ensure compliance with procedural and regulatory requirements.
• Prepares PV documents in Egypt, including but not limited to, aggregate reports, risk management plans, health risk assessments, and safety agreements to ensure submission within the required timelines. 
• Assists in the implementation and evaluation of the effectiveness of RMP-related activities in Egypt to ensure compliance with commitments made to regulatory authorities.
• Assists in the creation and update of local PV procedures, and National PSSF(s) for Egypt to ensure alignment with global procedures and regulatory requirements.
• Assists in the safety review of clinical study protocols, data management plans, statistical analysis reports, interim reports, and clinical study reports (CSRs) for studies in Egypt.
• Aids in the updates of the global product database to ensure it contains reliable and up to date product information for Egypt products.
• 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.
• Assists in the preparation of timely and accurate reports to meet company and Department requirements, policies, and standards.
  
  

Qualification

• Bachelor’s degree in pharmacy.
• Experience: 1:2 years of experience.
• Fluency in English, both written and verbal
• Analytical and organizational skills