Cross Sector SONIC Safety Operations Associate

Job description

Job Description

Requisition ID: 1805682684W

A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with partners in healthcare to touch the lives of more than a billion people every day throughout the world. Johnson & Johnson companies market leading products and services in three business segments: Consumer, Pharmaceuticals, and Medical Devices.

“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”

We have a new and exciting opportunity to hire a Cross Sector Safety SONIC Team Associate, for our Pharmacovigilance here at Vietnam's Ho Chi Minh office.

Job Purpose and Scope:

Fulfil the responsibility for the coordination and execution of assigned Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson's statutory and ethical responsibilities are met. Act as the main contact point with the Country Safety Leads (CSL), Local Safety Officers (LSO) Global Medical Organisation (GMO), Global Medical Safety (GMS) and Office of Consumer Medical Safety (OCMS) for assigned PV activities.

Core Job Responsibilities:



Case processing & HA reporting

·  Processing and management of all adverse events reports in accordance to global and regional procedures
·  Submitting regulatory reports to applicable regulatory authorities
·  Ensuring completion all required trainings prior to performing tasks
·  Responding to queries from CSL, LSO, OCMS and/or GMO and its service providers
·  Supporting CSL, LSO OCMS and/or GMO in investigation or documentation of Quality Investigation as needed
·  Any other pharmacovigilance duties, tasks or projects as assigned and agreed upon
·  Ensure that local processes, procedures and systems are in place for tracking and processing for Adverse Events (AE) and other safety information reportable to GMS and OCMS from spontaneous, and solicited sources.
·  Ensure comprehensive data processing to provide a complete description of the safety event.
·  Ensure that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information.

Collaborate & Support

·  Collaborate with CSL and LSO for adverse event reports processing and management.
·  Provide technical and strategic input and participate in projects led by ASPAC IPV team work streams.


Business Continuity

·  Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements
·  Ensure that a disaster recovery /business continuity plan is established in a risk-based manner to allow for continuation of critical business processes for PV

Desired profile

Qualifications

Qualifications

Experience, Skills and Knowledge:

·  Experience working in pharmacovigilance, knowledge of adverse event reporting in post-marketed products and clinical trials and knowledge Asia Pacific regulatory authority regulations
·  Medical, pharmacy or life-sciences master degree (or above)
·  Previous experience of working within the pharmaceutical industry on pharmacovigilance is preferred
·  Proactive
·  Excellent communication skills
·  Excellent organisational skills
·  Excellent team working skills
·  Project management skills
·  Time management skills
·  Excellent command of written and spoken English

Primary Location
Vietnam-Ho Chi Minh City-Ho Chi Minh City
Organization
Janssen-Cilag Ltd (7335)
Job Function
Pharmacovigilance
Requisition ID
1805682684W