PV/RA/QM ExecutiveID:54456
4,000 MYR ~ 7,000 MYRKota Damansara/Petaling Jaya12 days agoOverview
Salary
4,000 MYR ~ 7,000 MYR
Industry
Medical & Healthcare, Manufacturing(Pharmaceutical/Medical Equipment)
Job Description
• Maintains current knowledge, ensures compliance, and communicates with the relevant global, regional and local functions of the local regulatory requirements.
• Review, process and forwards safety events (pre-marketing and post-marketing) and/or other medically related information to Global PV and submits such safety events to the local health authority according to relevant global/local SOPs and local requirements.
• Perform review of abstracts and full articles to identify safety information from literature source.
• Support creation, management, and oversight of local RMP and all RMP-related PV activities.
• Support creation and management of local PSMF development.
• Liaise with investigational site and reporter as necessary regarding safety issues.
• Develop local PV training material and conduct PV training as per relevant SOPs.
• Prepare, review, update and maintain PV clauses in all relevant agreements from PV perspective.
• Manages and conducts oversight of Aggregate Report submission to the applicable local health authorities.
• Perform reconciliation of safety information with relevant internal and external functions.
• Supports audits and inspections, including external vendors and ensures execution of deviation and CAPA management.
• Develop and maintain PV Business Continuity Plan in accordance with global SOPs
• Review and ensure that the local PV system file and related SOPs are up to date.
• Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in the local market.
• Reviewing change requests and assess regulatory impact of product changes
• Reviewing proposed labelling for compliance with product branding, global/regional standards and applicable regulations
• Prepare, maintain, and supervise implementation, including training of current applicable local, regional, and global SOPs to ensure compliance in the company as required.
• Responsible for local GDP operational quality matters including product release, product hold and product recalls.
• Support or lead the local GDP inspections from MOH and perform GDP self-inspection.
• Support in addressing deviations, product complaints from customer to manufacturer, monitor the status until closure.
• Manage outsourced activities to ensure vendors meet the applicable local and global standards including auditing vendors.
Qualifications
Requirement
Education Background :
• Bachelor’s Degree in Pharmacy, Life Sciences or equivalent
Experience :
• Minimum 2 years experiences in RA and/or PV in pharmaceutical industry. Malaysian licensed Pharmacist preferred.
Require Skill :
• Strong organizational and process management skills. Able to multi-task effectively.
• Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
• Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
• Teamwork and collaboration with cross functional teams
• Excellent verbal and written communication skills in EnglishEnglish Level
-
Other Language
Malay, English
Additional Information
Benefit
Company group insurance
Medical
Dental
OpticalWorking Hour
9:00am ~ 6:00pm
Holiday
-
Job Function