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**Job Function: **
Product Safety
**Job Sub Function: **
Pharmacovigilance
Job Category:
Scientific/Technology
All Job Posting Locations:
Kibbutz Shefayim, Center District, Israel
Job Description:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Role Overview
The Experienced Specialist, Local Medical Safety (LMS) – Israel, is responsible for supporting the Country Safety Head and the Local QPPV in ensuring the effective operation, regulatory compliance, and continuous improvement of the local Pharmacovigilance (PV) system. The role operates in alignment with Israeli regulations and global company Pharmacovigilance standards.
Key Responsibilities
Local Pharmacovigilance System & Governance
- Support the Country Safety Head and Local QPPV in the ongoing management of the local PV system in accordance with local regulations, company policies, global PV standards, and third-party PV agreements.
- Ensure compliance with assigned training requirements and actively promote PV awareness across the organization.
- Act as an ambassador of the Local Medical Safety mission and values.
- Contribute to and/or lead LMS initiatives and projects at local, regional, and global levels.
ICSR Management & Operational Oversight
- Support the local collection, review, follow-up, reconciliation, and timely reporting of Individual Case Safety Reports (ICSRs).
- Maintain hands-on involvement in day-to-day ICSR operational activities, as required.
- Support the implementation and oversight of local literature monitoring activities.
- Oversee vendor-managed ICSR processing and PV-related activities, where applicable.
Compliance & Inspection Readiness
- Support continuous PV audit and inspection readiness at the local operating company level.
- Monitor inbound and outbound ICSR compliance and reporting timelines.
- Participate in ICSR reconciliations and review compliance dashboards to ensure data accuracy.
- Promote PV compliance awareness, ensuring accountability for findings and implementation of CAPAs.
- Escalate PV compliance risks and issues to the Country Safety Head in a timely manner.
- Support tracking, follow-up, and closure of Local Safety Unit (LSU) CAPAs and non-conformances.
Local Regulatory & Procedural Support
- Monitor changes in local Pharmacovigilance regulations and support impact assessments on local and global processes.
- Support the implementation of new or revised PV regulations and global procedural documents at the local level.
- Contribute to procedural document impact assessments and local implementation plans.
Pharmacovigilance Service Provision
- Support execution of day-to-day PV and medical safety activities for medicinal products and medical devices.
- Collaborate with the local Marketing Authorization Holder (MAH) to ensure regulatory compliance while supporting business objectives.
- Support the management, maintenance, and oversight of local Pharmacovigilance Agreements (PVAs).
- Assist in ensuring appropriate PV language is included in vendor, partner, and distributor agreements.
- Contribute relevant inputs to the EU Pharmacovigilance System Master File (PSMF).
- Support responses to Health Authority (HA) safety inquiries, including coordination, communication, and escalation activities.
Local Benefit–Risk & Medical Safety Activities
Medical Insights
- Develop and maintain in-depth knowledge of products, therapeutic areas, and disease pathways with a focus on safety aspects.
- Provide safety input to local cross-functional product and therapeutic area teams.
- Act as a safety Subject Matter Expert (SME) in meetings, trainings, and stakeholder interactions.
- Support LMS product teams as required.
Product Compliance & Risk Management
- Support local product compliance activities in collaboration with key stakeholders.
- Participate in local safety signal detection and evaluation activities, as applicable.
- Support the local implementation of Risk Management Plans (RMPs), including additional risk minimization measures.
- Assist in the preparation of local RMPs or RMP addendums and negotiations with local Health Authorities.
Training & Capability Building
- Support the rollout of global Adverse Event (AE) and Product Quality Complaint (PQC) training programs at the local level.
- Deliver and coordinate safety reporting training for internal teams, distributors, vendors, and external partners.
- Support the translation and localization of AE/PQC training materials as required.
Minimum Qualifications
- Bachelor’s degree in Life Sciences, Health Sciences, or Pharmaceutical Sciences; strong understanding of medical terminology required.
- Strong written and verbal communication skills, with the ability to communicate complex safety topics clearly and effectively.
- Fluency in English and Hebrew (additional languages are an advantage).
- Proven ability to collaborate, communicate, and negotiate effectively with internal stakeholders and external partners.
- Demonstrated ability to build and maintain strong working relationships with internal teams and regulatory authorities.
- Strong analytical and problem-solving skills, including the ability to identify compliance gaps, perform root cause analysis, and propose practical, compliant solutions.
- High level of computer proficiency, including MS Office and relevant safety databases and systems.
- Solid knowledge and application of global and local Pharmacovigilance regulations, guidelines, and internal policies.
- Ability to work independently with minimal supervision, manage multiple priorities, and meet strict timelines in a regulated environment.
Experience
- Minimum of 2+ years of experience in the pharmaceutical, medical device, or life sciences industry.
- At least 1 year of hands-on experience in a Pharmacovigilance / Medical Safety role is strongly preferred.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Clinical Operations, Coaching, Collaborating, 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