Job Description
Our Client:
Our client is one of the top leading pharmaceutical companies, with HQ in Japan. They have more than 5,000 employees and has grown into a company that can deliver their products to people in more than 80 countries around the world. Due to expansion of their Singapore office, they are actively looking for a PV/RA/QM Executive to join in their efforts.
The Responsibilities:
* 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
* 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 operational quality matters including product hold and product recalls
* 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
The Requirements:
* Minimum Bachelor's Degree in Pharmacy, Life Sciences or equivalent with 1 - 3 years' experience in PV and/or RA experience in Singapore Pharmaceutical Industry
* Possess a Pharmacist License in Singapore is preferred
* Strong organizational and process management skills
* Able to multitask and manage relations with internal and external stakeholders
* Teamwork and collaboration with cross functional teams
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.