Connecting...

PV/RA - ASSISTANT MANAGER

Job title: PV/RA - ASSISTANT MANAGER
Contract type: Permanent
Location: Kuala Lumpur
Specialisation:
Salary: RM7,000 - RM9,000
Start date: 24-09-2021
Reference: PR/146030
Contact details: Jing May How
Contact email: jingmay.how@jac-recruitment.com
Job published: August 23, 2021 14:00
JOB RESPONSIBILITIES
  • 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.
JOB REQUIREMENTS 
  • 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).
#LI-JACMY
#statekl