Medical Affairs and Pharmacovigilance Sr.Officer

JOB PURPOSE
This role is responsible for acting as the Qualified Person for
Pharmacovigilance in Saudi Arabia and is focused on drug safety monitoring and
on performing various drug safety-related tasks in support of Hikma marketed
products and Hikma-sponsored clinical studies , and provides up to date,
accurate, and relevant medical, pharmaceutical, and technical information
related to Hikma products in response to internal and external medical
information enquiries received in accordance with Hikma Global and Local SOPs,
safety data exchange agreements with third parties, and applicable
regulations.
KEY ACCOUNTABILITIES
* Monitor PV requirements in Saudi Arabia.
* Have an overview of the safety profiles and any emerging safety concerns in relation to Hikma products in Saudi Arabia.
* Be aware of any conditions or obligations adopted as part of Hikma marketing authorizations and other commitments relating to safety or the safe use of Hikma products in Saudi Arabia.
* Be aware of the content of risk management plans and risk minimization measures.
* Be involved in the review and sign-off of protocols of post-authorization safety studies conducted in Saudi Arabia.
* Be aware of post-authorization safety studies requested by Saudi FDA including the results of such studies.
* Ensure conduct of PV (including local non-indexed literature screening) and submission of all PV-related documents according to applicable requirements in Saudi Arabia.
* Ensure the necessary quality, including the correctness and completeness, of PV data submitted to Saudi FDA.
* Ensure a full and prompt response to any request from Saudi FDA for the provision of additional information necessary for the benefit-risk evaluation of a Hikma product.
* Provide any other information relevant to the benefit-risk evaluation to Saudi FDA.
* Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals).
* Act as a single PV contact point for Saudi FDA on a ‎24-hour basis and as a contact point for PV audits and inspections in Saudi Arabia.
* Prepare/revise Saudi Arabia PV standard operating procedures (SOPs).
* Prepare/revise safety data exchange agreements (SDEAs) with Hikma-Al Jazeera Pharmaceutical Industries (JPI) contractual partners.
* Process medical information enquiries received by phone or email.
* Search Hikma product data and documents, as well as various medical and scientific literature to retrieve information needed to generate clinically relevant, balanced, evidence-based answers to the incoming enquiries.
* Document required medical information enquiry details, including follow-ups if applicable.
* Identify, collect, and document relevant information about adverse events and/or product quality complaints and transfer it to the Pharmacovigilance and/or QA departments and/or business partners within required timelines.
* Conduct searches of the medical and scientific literature in support of the requests from internal customers.
* Provide medical/scientific input into the development and execution of non-interventional studies and investigator-initiated studies.

Communications & Working Relationship:
Internal:
* Pharmacovigilance
* Medical Affairs
* Regulatory Affairs
* Commercial teams
* Compliance
* R&D

External:
* Regulatory authorities
* KOLs
* Prescribers and healthcare professionals
* Medical institutions

Qualifications & Experiences
* Minimum: MD or PharmD or Pharmacy or B.A./B.S. degree
* Minimum: ‎2-‎4 years of related industry experience

SKILLS
* Change and Innovation
* Collaboration and Teamwork
* Customer Focus Internal/External
* Communication and Influence
* Planning and Organizing
* Initiative and Drive for Results