Johnson & Johnson Careers

Country Safety Lead

Singapore, Singapore; Philippines; Malaysia; Thailand; Vietnam; Indonesia
Drug & Product Safety Operations


Job Description

Requisition ID: 1905730651W

The Johnson & Johnson Family of Companies & Actelion

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 Country Safety Lead, for our Pharmacovigilance here at Singapore’s Ascent office.

Job Purpose and Scope:
  • Fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson & Actelion’s statutory and ethical responsibilities are met. 
  • Act as the Local Operating Company (LOC)’s and assigned territories’ (All South East Asia, India, Hong Kong, Taiwan as applicable) main contact point for PV matters with the local Health Authority, Global Medical Organisation (GMO), Global Medical Safety (GMS) and Actelion Global Drug Safety (GDS).
  • Provide strategic leadership and support LOC to meet all global and local PV responsibilities.
Oversight of the PV System 
  • Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
  • Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
  • Advise the business on the PV impact of local organized data collection programs.
  • Escalate compliance issues in a timely manner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
  • Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
  • Identify periods of high PV workload and manage PV resource appropriately to address them.
  • Support and lead process improvements to optimize the PV system and make best use of PV resource.
  • Work collaboratively with regional affiliates to ensure consistency of approach across groups.
  • Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
  • Provide high quality and consistent input to development of local safety initiatives and programs.
  • Plan and deploy skilled resources against project priorities, if applicable
  • Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and GDS.
Case processing & HA reporting 
  • Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
  • Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
  • Advise the business on the PV impact of local organized data collection programs.
  • Escalate compliance issues in a timely manner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
  • Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
  • Identify periods of high PV workload and manage PV resource appropriately to address them.
  • Support and lead process improvements to optimize the PV system and make best use of PV resource.
  • Work collaboratively with regional affiliates to ensure consistency of approach across groups.
  • Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
  • Provide high quality and consistent input to development of local safety initiatives and programs.
  • Plan and deploy skilled resources against project priorities, if applicable
  • Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and GDS.
Compliance 
  • Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
  • Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
  • Advise the business on the PV impact of local organized data collection programs.
  • Escalate compliance issues in a timely manner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
  • Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
  • Identify periods of high PV workload and manage PV resource appropriately to address them.
  • Support and lead process improvements to optimize the PV system and make best use of PV resource.
  • Work collaboratively with regional affiliates to ensure consistency of approach across groups.
  • Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
  • Provide high quality and consistent input to development of local safety initiatives and programs.
  • Plan and deploy skilled resources against project priorities, if applicable
  • Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and GDS.
Collaborate & Support

  • Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. 
  • Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
  • Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS, GDS or appropriate case management centre and Health Authority, as required.
  • Where applicable, support the Qualified Person Pharmacovigilance (QPPV) to provide safety-related regulatory communication (e.g., response to request for information from local Health Authority, including the provision of information about the volume of sales or prescription, as appropriate.
  • Participate in the Product Issue Management teams, as appropriate.
  • Provide technical and strategic input and participate in projects led by the regional GMS, GDS team and GMS, GDS work streams.


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
Singapore-Singapore-Singapore-
Other Locations
Asia Pacific-Philippines, Asia Pacific-Malaysia, Asia Pacific-Thailand, Asia Pacific-Vietnam, Asia Pacific-Indonesia
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Drug & Product Safety Operations
Requisition ID
1905730651W