- Manage safety queries and other significant safety information locally, inclusive of crisis management.
- Prepare, maintain and implement the necessary SOPs that meet the requirements of the regulations with respect to drug safety.
- Conduct local literature search and ensure any other safety data deemed fit for inclusion in the PSUR/PBRER or signal management process.
- Review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
- Continual risk assessment of local PV operations, including early notification of any risks.
- Responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations and registration renewals.
- Manage Import License and associated Product List in timely manner to ensure continuous supply of stock.
- To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
- Degree in Pharmacy (with Pharmacist License).
- Minimum 5 years or more in PV and RA role in pharmaceutical company.
- Able to work independently and with others, positive attitude, willingness to embrace new skills.
- Fluency in English and Bahasa Malaysia (written and spoken).
- IT: Microsoft Office (PowerPoint, Excel, Word).