Pharmacovigilance Associate
Company: StrugoPharm
- Location: Tel Mond, Israel
- Work mode: Hybrid
- Seniority: Entry level
- Employment type: Full-time
- Posted: 12 days ago
- Offer language: English
Job description
Company Description StrugoPharm is a pharmaceutical company with over 25 years of experience in regulatory submissions and product lifecycle management for chemical and biological entities, advanced therapies, generic products, and medical devices.
StrugoPharm’s team is dedicated to meeting customer expectations through professionalism, reliability, and close collaboration. The company has successfully represented international firms in Israel, building a stable market presence based on integrity and extensive industry experience.
Role Description The Pharmacovigilance Associate is a full-time role responsible for supporting safety monitoring and reporting activities across StrugoPharm’s product portfolio. This position involves collecting, reviewing, and documenting adverse event reports, performing initial case assessments, and preparing accurate narratives and safety documentation. The role includes performing quality control checks on safety data, supporting regulatory safety submissions, and ensuring compliance with local and international pharmacovigilance requirements. The associate will collaborate with regulatory affairs, medical, and quality teams to maintain up-to-date safety files and support inspections or audits.
This is a hybrid role based in Tel Mond.
Qualifications
- Strong background in Pharmacy or related life sciences, with the ability to understand clinical and pharmaceutical information.
- Proficiency in narrative writing for case reports and safety documentation, with clear, concise, and accurate medical communication skills.
- Experience with Quality Control processes, including data validation, document review, and adherence to SOPs and regulatory standards.
- Knowledge of Regulatory Affairs and pharmacovigilance regulations, preferably including EMA and FDA guidelines and local Israeli requirements.
- Familiarity with Medical Coding systems (e.g., MedDRA, WHO Drug) for accurate coding of adverse events and medications.
- Excellent attention to detail, analytical skills, and ability to manage multiple cases and deadlines in a structured manner.
- Strong written and spoken communication skills in English; Hebrew proficiency is necessary.
- Bachelor’s degree in Pharmacy, Pharmacology, Life Sciences, or a related field; previous pharmacovigilance experience is an asset.
- Ability to work effectively in a hybrid environment, collaborating with cross-functional teams and maintaining confidentiality of patient and product data.
