Executive Search Firm Monroe Consulting Group Philippines is recruiting a Pharmacovigilance - Quality Assurance Assistant on behalf of a multinational CRO company. The role will report to the Regional Head with mainly remote working setup with night shift work schedule.
Job Summary:
- The Quality Assurance Assistantprovides administrative support to the Quality Assurance (QA) department. Responsibilities include delegating administrative tasks related to various aspects to support the quality assurance processes and associated functions. Assist with updating and maintaining systems, procedures and work practices to a level that will pass international quality assurance audits in accordance with the specifications of ICH GCP, SA GCP, FDA and other relevant guidelines.
Essential Functions:
- Assist with relevant preparation for planned audits of Company documents and systems.
- Assist with maintenance of relevant tracking databases, as required.
- Provide general administrative support to the QA team, as required.
- Assist with frequent reviews of national and international regulatory websites, to stay abreast of updates on general clinical research guidelines.
- Other ad hoc tasks associated with QA functions, as required.
- Assist with administrative tasks and responsibilities in other departments, as required.
Qualifications:
- Bachelor's Degree in Pharmacy
- At least 3 years of experience in pharmacovigilance related activities
- Expertise in relevant therapeutic areas as required for processing Adverse events (AEs).
- Ability to work effectively within a team to attain a shared goal.
- Strong attention to detail.
- Computer and word processing skills (MS office)
- Adequate knowledge of relevant Company SOPs, ICH GCP and SA GCP guidelines.
- Excellent communication and organizational skills; strong attention to detail.
