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Lilly Pharmacovigilance Associate, North East Africa in Egypt

Job Category:

Medical

Type of Employment:

Full-Time Employment - FTE

Responsibilities:

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

Basic Qualificiations:

  • 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

Additional Skills/Preferences:

  • 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

Additional Information:

Company Overview:

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.

Posted Date:

Keyword:

Region: Europe; Middle East; Africa

City:

State: CAIRO

Country: Egypt

Location Details:

Req Id: 51482BR

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