Quality Assurance & Pharmacovigilance Supervisor

Location
marker Head Office
Job Category
marker Supervisor
Application Posted
marker July 28, 2023
Responsibilities

Coordinate with all relevant internal functions to manage the operational processes of pharmacovigilance, complaint handling, recall, and hold within designated timelines.

Act as the point of contact between clients and the company to handle pharmacovigilance activities, complaints, recalls, mock recalls, and holds.

Monitor and control the status of complaint sample shipments from branches to the National Distribution Center (NDC), as well as recall and hold activities.

Conduct thorough analysis and provide summaries of branch performance in complaint handling, recall, and hold, reporting on a monthly basis.

Perform revisions of Standard Operating Procedures (SOPs) related to these functions and ensure their implementation in daily processes.

Undertake special projects as assigned by the direct superior.

Facilitate training and development programs for the Branch Regulatory and Quality Assurance team to enhance their understanding of pharmacovigilance and complaint handling.

Collaborate with other functions to fulfill client requirements regarding pharmacovigilance, complaints, recalls, mock recalls, and holds.

Assist and handle Quality Assurance (QA) needs for sourcing and purchasing, while maintaining records of QA budget and expenses.

Qualifications

Fresh graduates with a degree in Apothecary or possess at least 1 year of experience in QA & Pharmacovigilance.

Strong relationship development and management skills are essential to build robust internal and external relationships.

The ability to build and lead effective cross-functional teams

Proficiency in both Bahasa and English communication is a must.

Candidates must demonstrate the ability to maintain meticulous records and ensure excellent traceability of documents and data