Pharmacovigilance and Quality Specialist

Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.

Position Summary

Responsible for ensuring compliance in Malaysia on Pharmacovigilance regulations, Good Distribution Practices and Quality requirements. Acting as the key interface between the regional Pharmacovigilance/Quality functions and the local business, ensuring appropriate communication with the Country Manager and other relevant departments such as Commercial, Legal and Medical Information.

Job Responsibilities

To act as the local Person in charge of Pharmacovigilance (LPVRP) according to local legislation in the countries concerned and aligned with Glenmark's standards and processes.

In cooperation with Global PV and the EU QPPV to provide local regulatory authorities with any information relevant to the benefit or risk evaluation of a medicinal product

Set up and maintain an efficient pharmacovigilance system in compliance with local regulations that allows collection, documentation and forwarding of adverse events received to Global PV and timely submission to local agencies as required.

Immediately, inform Global PV of Regulatory Authority enquiries as well as of changes concerning national PV regulations.

Implement commitments from inspections, audits and identified gaps and coordinate corrective actions in cooperation with QA, GPV compliance and Training.

To provide the required data analysis and monthly KPI reporting.

Reviewing batch records, e.g. Certificates of Analysis, Certificate of Conformity, and incoming inspection. Review of temperature and humidity data logged during transportation, highlighting any deviations for the RP/QP's attention and review. Management of batch documentation.

Communication with Supply Chain, manufacturing, warehouses, wholesalers, packaging sites and customers to follow-up on and obtain supply requested information when needed.

Support in the management, further development and optimization of the local quality system as part of the implementation of the European QMS:

1. Responsible for keeping and/or monitoring local databases of the different Quality Systems (e.g. change control, deviation, CAPA, complaint, training)
2. Managing of GxP related tasks including, but not limited to: Documentation system, Deviations, Change Control, CAPA, Customer Complaints, Recall management, Training system.
3. Performance of self-inspections and follow-up activities; liaising with the European QA function, the Glenmark manufacturing sites and third-party suppliers to secure the necessary documentation to the required level of quality.
4. Inspection preparations.

Participation in local / regional projects on an ad hoc basis, as required.

Requirements

Bachelor's degree in pharmacy.

Minimum of one-year experience in the pharmaceutical industry with direct pharmacovigilance experience preferred.

Broad understanding of regulatory requirements and specifics in the market.

Knowledge, judgment and confidence to make decisions when faced with ambiguity.

Strong project management skills with ability to priorities effectively.

Attention to detail.

Analytical thinking and problems solving.

Excellent verbal and written communication skills in English.

Ability to work independently and work in a team.