Pharmacovigilance Associate JB-67

About the Company

Protalix BioTherapeutics is a pharmaceutical company developing innovative therapies for rare diseases with significant unmet medical needs, leveraging its proprietary plant cell–based protein expression platform, ProCellEx®, alongside additional modalities. Protalix has successfully commercialized two recombinant protein–based products and is advancing additional programs in clinical development.

About the Role

We are seeking a motivated Pharmacovigilance Associate to join our dynamic and growing team.

Responsibilities

• Manage safety surveillance activities for products in clinical development, including case processing, safety data review, signal detection, literature review, and coordination of internal safety committees.
• Develop, maintain, and deliver training on PV SOPs and safety procedures in accordance with regulatory requirements.
• Review and contribute to safety sections of clinical and regulatory documents (IBs, protocols, ICFs, CSRs, DSURs).
• Manage Safety Data Exchange Agreements (SDEAs) with partners.
• Support clinical trial operations throughout the study lifecycle.

Qualifications

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

Required Skills

• At least 5 years of experience in Pharmacovigilance/Safety in a pharmaceutical or biotech environment.
• Strong knowledge of global PV regulations (ICH, GCP, FDA, EMA).
• Hands-on experience in clinical trial safety management.
• Experience working with CROs, vendors, and partners – advantage.
• Experience in clinical operations activities – advantage.
• Ability to work independently, manage multiple priorities, and collaborate cross-functionally.
• Excellent written and verbal English skills.

Preferred Skills

• Experience working with CROs, vendors, and partners – advantage.
• Experience in clinical operations activities – advantage.

Pay range and compensation package

Full-time position, with an option for 60% position.

Equal Opportunity Statement

We are committed to diversity and inclusivity.