Responsibilities

Regulatory

• Drug product registration/ product variation applications.
• Follow up amendments related to MA license variation
• Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders
• Maintain / manage registration files and RA databases in shared drive of RA.
• Proof reading product package label against approved label and the labeling regulatory requirement.
• Communication with regulatory authorities and company headquarters.
• Submission of drug reimbursement application to HIRA or MoWH.
• Support drug reimbursement project.
• Promotional material (e.g., product brochure) review against regulations and product approved label.
• If required, answer/fulfill requests / queries originating from local authorities(MFDS, MOHW, KPIS, and HIRA etc.)

Pharmacovigilance

• Handling of drug safety related information and report it to HQ and local authority –Serious adverse events from studies and spontaneous adverse events occurred from products
• Report monthly reconciliation with MIS & Quality complaints
• Provide PV training to relevant stakeholders
• Fulfill the required tasks according to local & global procedure and regulations.
• Management of local PV SOPs
• Ensure a scientific and regulatory intelligence related to Pharmacovigilance.
• Learn HQ PV system & procedures and assess/ implement it to local SOPs & procedures.
•  Fulfill MFDS PV inspection
• To be registered to MFDS as PV responsible pharmacist.

Educations & Experiences

• Qualification of pharmacist in Bachelor or Higher degree.  

• 5-7 years’ experience in RA and/or PV in pharmaceutical company

Skills & Qualifications

• Proficient in MS Office, including Word, Excel and PowerPoint

• Effective communication and interpersonal skills

• Good verbal and writing English skill is preferred

• Knowledge of pharmaceutical regulations