JAC Recruitment Malaysia is looking for new potential candidates to fill in for DRUG SAFETY SPECIALIST (REF: HJ) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- 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.
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Pharmacy/Pharmacology or equivalent.
- Minimum 5 years or more in Pharmacovigilance and Regulatory Affairs 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).
We established since April 1994 in Malaysia and has been providing accurate and high quality recruitment service to our clients. We introduce highly skilled, experienced and professional personnel, spanning through a wide range of expertise; Executive Placement, Staff Placement, Native Japanese, Japanese Speaking, and Multilingual Talent
- Our consultants are well trained professional and has in-depth industry specific knowledge
- We are committed to provide borderless operation with the same high standard of service everywhere
- We Place the right talents, to the right positions, at the right companies with joy!
How To Apply
If you confident and feel that this job is suitable to you, go ahead take your action now.
Hope you find your dream hospital job in Selangor.