Lilly Pharmacovigilance Associate, North East Africa in Egypt
Type of Employment:
Full-Time Employment - FTE
The purpose of the QPPV role is to identify opportunities and proposes alternatives for process improvements to accelerate documents availability according to the business need and to use data to support affiliate pharmacovigilance performance or needs. Pharmacovigilance Associate is responsible for the pharmacovigilance processes in North East Africa including the local implementation of global Medical and Safety Standard Operating Procedures and local regulatory requirements for Adverse Event Reporting and Pharmacovigilance to perform pharmacovigilance-related support of local business.
Responsible for optimizing the value of Lilly products through the promotion of patient safety
Identifies the presence of an adverse event and obtains the relevant information regarding the event from the initial reporter
Responsible for the initial review and entry of adverse event case reports into the Local Affiliate Module (LAM) of the Lilly Safety System (I-SS)
Case Management (LAM) Quality Review - concerning cases received by Egyptian affiliate and follow up.
Responsible for generating the necessary expedited case reports that are required to meet local regulatory requirements
Responsible for Periodic submissions to local regulatory agencies according to Lilly processes and local regulatory requirements (PSURs)
Establish and maintain the Market Authorization Holders (MAH) Pharmacovigilance System (including all activities which contribute to the detection, assessment. understanding and communication of safety information, as well as risk management activities). In addition, the local QPPV is responsible for maintaining the MAH Phamacovigilance System in Egypt.
Develop the local Phamacovigilance processes for the affiliate aligned with the current ASQS procedures, policies and local regulations
Collaborate in development and maintenance of local safety agreement with TPOs to ensure accuracy of safety language and requirements
Should submit the EU RMP & Egyptian Display RMP as required by Egypt PV Center & during license submission process
Followup the updates on the PSMF (Global document) to be submitted to the Egyptian Pharmacovigilance Center upon request & implement the Pharmacovigilance subsystem file (PSSF) as applicable.
Ensures SOPs are well understood across the affiliate, leading and providing clarification on local implementation
Supports the development of global SOPs to ensure alignment with local laws and regulation
Collaborate in fulfilment of any post-authorization commitments related to the Drug Safety Department for example the updated SmPC, Dear health care professional letter [DHPL] & others (if applicable)
Proactively check if any new PV regulations/updates issued by regulatory authorities for NEA & insure the implementation
Bachelor's degree of medicine or pharmacy as required by the MOH
1-3 years of drug safety or pharmacovigilance experience is a must
Computer skills (Microsoft Word, Excel, power point)
Proficiency in spoken and written English language
Excellent communication and negotiation skills
Organization skills and attention to details
Ability to work under pressure and tight timelines
Knowledge of global regulations with respect to pharmacovigilance
Knowledge and understanding of Global Product Safety policies and procedures
Foundational knowledge and understanding of the local and global regulatory procedures as well as European one
Products & disease knowledge
Lilly is a global health care leader that unites caring with discovery to make life better for people around the world. For more than a century, we have stayed true to a core set of values—excellence, integrity, and respect for people—that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
Region: Europe; Middle East; Africa
Req Id: 51482BR