Pharmacovigilance Associate JB-60

Protalix BioTherapeutics is a pharmaceutical company developing innovative therapies for rare diseases with significant unmet needs. We leverage our proprietary plant cell–based protein expression platform, ProCellEx®, along with other modalities including small molecules and antibodies.

Protalix has successfully commercialized two recombinant protein–based products, is advancing a gout program currently in Phase 2 development, and continues to build a pipeline focused on renal diseases while exploring novel technologies and early-stage opportunities.

If you are looking to join a dynamic, professional team that supports personal and career growth, we would be happy to hear from you.

Key Responsibilities

• Manage the company’s safety surveillance activities for products under clinical development, including case processing, periodic safety data assessments, signal detection, literature reviews, preparation and coordination of internal safety committees, and maintenance of an overall safety surveillance plan.
• Develop, maintain, and deliver training on internal PV SOPs and safety procedures, ensuring alignment with evolving regulatory requirements.
• Review/contribute to safety content for clinical and regulatory documents, including IBs, protocols, ICFs, CSRs, and DSURs.
• Execute and manage Safety Data Exchange Agreements (SDEA) with partners for post-marketing products.
• Support and manage clinical trial operations activities throughout the clinical study lifecycle.

Required Expertise and Experience

• Proven experience in Pharmacovigilance and Safety management within a pharmaceutical or biotechnology environment (≥5 years).
• Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GCP, FDA, EMA).
• Hands-on experience in managing safety activities in clinical trials.
• Working with external safety/pharmacovigilance vendors, CROs, and partners - advantage.
• Experience in clinical operation activities including study start-up, conduct, and close-out. Review and support study plans, experience in eCRF, IRT, and eTMF activities and ensure appropriate clinical trial monitoring and documentation – advantage.
• Ability to work independently, manage multiple priorities, and lead safety and operational activities end-to-end.
• Strong communication, organizational and cross functional collaboration skills.
• High level verbal and written English.
• The position is in Karmiel
• Presence on site at least 3 times a week

Education

• BSc or MSc in Life Sciences, Pharmacy, Medicine, Nursing, Public Health, or a related scientific discipline.
• Advanced degree (PharmD, MD, or PhD) – an advantage.