REF 1507840
14.04.2024 | Sharjah | full time
General
Location: Sharjah
Occupancy: full time
To join : immediately
Description
As a Pharmacovigilance Manager, your responsibility is to manage the safety profile of new drugs in clinical
trials, oversee case-processing activities through all phases of development and perform regulatory reporting
and medical monitoring tasks. You will manage the set-up, handover, and oversight of the Pharmacovigilance
(PV) Hub’s various regional requirements (Middle East and Africa), ensuring high PV standards and
following regulatory requirements across designated countries. You will be responsible to ensure there is
close alignment with the Director of Medical and Clinical Affairs and respective managerial level positions
to comply with governance requirements.

KEY TASKS AND RESPONSIBILITIES:

• Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system for Emmaus
Medical.
• Maintain awareness and ensure adherence to established and updated local and global processes and
guidelines as well as national and international regulations and guidelines for pharmacovigilance.
• Ensure PV business continuity and after hours availability.
• Lead and coordinate internal and external PV audits and inspections.
• Monitor PV system performance and compliance of partners and distributors.
• Maintain expertise in country as well as worldwide regulations and guidelines and promote increased
awareness of the legislative and regulatory environment in the country.
• Accountable for all strategic PV activities for MEA.
• Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the
safety profile of Emmaus Medical products and to meet regulatory requirements.
• Act as the responsible contact person in the region, internally and externally, for safety-related aspects
and PV.
• Ensure internal regulatory/PV processes and procedures are well documented and support compliant
regulatory/PV activities.
• Perform other duties as assigned
Requirements
Experience: 3 - 5 years
Provisions
Salary: to be discussed
Medical insurance provided
Accommodation
Publisher
direct employer
50 - 200 employees