Local Medical Safety Specialist, Malaysia, Brunei & Indonesia

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

Scientific/Technology

All Job Posting Locations:

Petaling Jaya, Selangor, Malaysia

Job Description:

The Local Medical Safety Specialist, supports pharmacovigilance activities for Johnson & Johnson products across Malaysia, Brunei and Indonesia, ensuring local safety systems, processes and activities remain compliant with applicable regulations, company procedures and PV agreements.

The Local Medical Safety Specialist, Malaysia will report to and work closely with the Cluster Safety Lead, Malaysia, Brunei and Indonesia within the Local Medical Safety (LMS) organization to support oversight of local PV operations, compliance, risk management and stakeholder engagement:

• Support oversight of Local Operating Company (LOC) pharmacovigilance activities across Malaysia, Brunei and Indonesia, ensuring compliance with local regulations, company policies/procedures and applicable third-party PV agreements.
• Support maintenance of appropriate PV, risk management and record management processes to enable effective oversight of products within scope.
• Manage Local Medical Safety activities to:
  • Enable proactive benefit-risk management throughout the product lifecycle by translating global safety information into locally relevant insights and actions.
  • Support safety reporting and related PV activities required by Marketing Authorization Holders (MAHs), study sponsors and applicable local requirements.

PRINCIPLE RESPONSIBILITIES

• Act as Locally Nominated Back-up Person for Pharmacovigilance
  • Serve as the locally nominated back-up PV contact, as required by national law/regulation, and collaborate with QPPV offices or relevant PV leadership as applicable.

 

• Safety Management & Reporting:
  • Support local processes and systems for end-to-end management of adverse events, product quality complaints with adverse events, special situation reports and related safety information.
  • Support timely management and submission of safety information in line with company procedures and local regulatory timelines.
  • Work with the IQVIA case management specialist to provide oversight of end-to-end case management activities under the centralized model, from case intake to submission, including follow-up requests, reconciliation, local medical or scientific literature search, translation of Individual Case Safety Reports (ICSRs), Health Authority correspondence, regulatory intelligence, and submission to the local Health Authority (HA), as applicable.
  • Support local review, preparation, submission and tracking of aggregate reports, where required by local regulations and applicable PV agreements.
  • Support oversight of local data-generating activities to ensure appropriate safety review and adverse event reporting pathways are reflected in project documents, as applicable.

• Local Medical Safety Management Activities:
  • Develop and maintain product, therapeutic area and disease pathway knowledge to support local Medical Affairs, Regulatory Affairs and other stakeholders with relevant safety insights.
  • Provide safety input in cross-functional discussions and support training on relevant product safety topics, as appropriate.
  • Maintain oversight of Risk Management Plan (RMP) updates and prepare local RMPs/Addendums, as applicable; support local safety signal detection activities, where applicable.
  • Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety.
  • Ensure timely communication of relevant new safety information to Health Authorities, Healthcare Professionals and internal stakeholders, including DHPCs, CCDS implementation into local labels and USRs, where applicable.
  • Support additional risk minimization activities and DHPC management, including submission to HA for approval and supporting the implementation plan, as applicable.
  • Provide safety input into local protocols and project documents, including clinical trials, non-interventional studies, related research activities and patient support programs, to ensure appropriate safety reporting requirements are addressed.

• Support implementation of applicable PV procedural documents, local implementation documents and controlled processes, ensuring adherence to local, regional and global requirements.
• Support PV training and awareness activities for local employees, distributors and vendors, including AE/PQC training and documentation, as applicable.
• Support local PV agreement implementation, training and adherence monitoring, as applicable.
• Monitor local PV regulatory requirements and support impact assessment, implementation and communication of regulatory changes to relevant stakeholders.
• Support PV audit and inspection readiness, including preparation, coordination of document requests, stakeholder follow-up and tracking of related actions to completion. 
• Support business continuity arrangements for critical PV activities, including after-hours adverse event reporting coverage and inspection readiness, as applicable.

QUALIFICATIONS

• Bachelor’s degree in the field of Medical, Life Sciences, Pharmacy or related
• 1 to 3 years of relevant work experience in pharmacovigilance, pharmaceutical regulations, medical safety, quality, regulatory affairs or related areas preferred.

• Experience
  • Scientific study and experience in pharmaceutical regulations and R&D processes.
  • Experience supporting PV activities, safety reporting, compliance oversight or stakeholder coordination in a pharmaceutical or healthcare environment is preferred. 
• Essential Knowledge & Skills
  • Sound scientific, medical or pharmacy knowledge, with proficiency in medical terminology and an understanding of product safety principles.
  • Strong organizational skills with the ability to manage multiple priorities, follow timelines and support issue resolution.
  • Computer literacy, including Microsoft Office; familiarity with safety databases or PV systems is an advantage.
  • Awareness of pharmacovigilance, drug development, pharmacology and applicable local regulatory requirements.
  • Good verbal and written communication skills; fluency in English is required.
  • Ability to communicate effectively and build collaborative relationships with internal stakeholders, external partners and Health Authorities, as applicable.
  • Demonstrated attention to detail, accountability and ability to work independently while escalating issues appropriately.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Clinical Operations, Coaching, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy