Experienced Specialist, Local Medical Safety at Johnson & Johnson

Breda, North Brabant, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in local Pharmacovigilance (PV) systems and compliance with local, regional, and global regulations, company policies, and PV agreements
Experience in ICSR management, including collection, review, reporting, reconciliation, follow-up, and literature processes
Knowledge of vendor oversight and management
Proficiency in PV audit/inspection readiness and compliance monitoring (e.g., reconciliations, dashboards, CAPAs)
Ability to review, translate, prepare, submit, and track aggregate reports per local regulations
Awareness and implementation of local PV regulatory changes, including impact assessments and procedural document updates
Skills in managing PV activities for medicinal and non-medicinal products (e.g., medical devices)
Experience collaborating with MAH, Regulatory Affairs, and stakeholders on PV agreements, contracts, and PSMF contributions

Responsibilities

Ensure local PV system compliance with regulations, policies, and agreements at all levels
Manage ICSR collection, review, reporting, reconciliation, follow-up, and literature processes; oversee vendor activities
Maintain PV audit/inspection readiness; oversee ICSR compliance; perform reconciliations and review dashboards with MSQ
Increase PV compliance awareness; own findings and CAPAs; escalate issues to CSH
Address follow-up actions from LSU non-conformances and CAPAs
Review, translate, prepare, submit, and track aggregate reports; support GMS synchronization with local RA
Monitor local PV regulation changes; assess impacts; notify stakeholders; implement updates; support global procedural documents
Provide input for LMS processes, systems, policies; engage in industry associations
Ensure satisfactory PV and safety activities for products; collaborate with MAH
Manage and implement local PVAs; support PV language in vendor contracts
Provide timely EU PSMF contributions

Skills

Pharmacovigilance

ICSR Management

Regulatory Compliance

Audit Readiness

Inspection Preparedness

Literature Review

Vendor Oversight

CAPA

Safety Reporting

Reconciliation

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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