Pharmacovigilance Manager

Arbour Group (a PharmaLex company) one of the leading global providers of digital compliance products and services for the life sciences industry, is looking for a full-time remote  Pharmacovigilance Manager to join their team. The role will be responsible for the maintenance of the marketing authorization holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations. Main Tasks:

• Close cooperation with the global PV system of the client as well as related global and local departments and functions
• Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
• Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
• Assume responsibility in case of planned or unplanned absence of regional lead
• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety
• Integrated first Level Medical Information and PQC Support
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties

• Bachelor's degree in Medicine, Pharmacy or any Life Sciences course
• Several years’ experience and profound knowledge in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
• Detailed knowledge of related SOPs (global and local)
• Participation in all relevant courses of instruction such as internal trainings and applicable external courses
• Experience in all operative tasks that are performed by the members of the pharmacovigilance department
• Familiarity with industry principles of pharmacovigilance
• Ability to organize operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
• Ability to adjust rapidly to new, unknown, challenging situations
• Ability to analyze and solve problems and to develop possible solutions
• Autonomous, concentrated and high-quality work
• Strong sense of responsibility and ability to work in a team
• Very good command of English
• Must be a citizen of the Philippines
• Willing to work in a mid shift schedule

• Work in a company with a solid track record of performance
• Have a remote work arrangement and employment benefits (upon hire) on top of a competitive salary offer 
• Have the opportunity to work with a diverse multi-functional team and collaborate with different industry experts and SMEs both locally and internationally