LQPPV & Local Patient Safety Officer

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About The Role

Merck KGaA, Darmstadt, Germany is seeking an experienced Local Qualified Person for Pharmacovigilance (LQPPV) & Local Patient Safety Officer (LPSO) for its Israel affiliate. As a key regulatory and patient safety role, you will be nominated as a contact person for internal and external safety-related matters and will exchange information within the Patient Safety Center (PSC) Mediterranean as well as with local key stakeholders (i.e., Medical Affairs, Regulatory Affairs, Healthcare Quality, Clinical Operations, and Commercial Organization etc.).

Key Responsibilities

• Serve as the designated LQPPV and single point of contact for the Israeli MOH on all PV matters, with 24/7 availability for urgent safety communications and regulatory inspections
• Ensure full oversight and timely submission of ICSRs, PBRERs, Safety Signals and other PV deliverables in line with local legislation
• Monitor Israeli MOH communications and local PV legislation for changes; assess impact and drive implementation
• Lead and execute local PV operational tasks, maintain the local PV file, and oversee PV system quality and compliance (KPIs, CAPAs, audits)
• Manage local PV vendors and business partners, including oversight of contractual PV agreements
• Ensure proper implementation of Risk Management Plans (RMPs) and additional risk minimization measures in collaboration with local and global teams
• Ensure oversight of safety signals, benefit-risk evaluations, and emergency safety situations, providing LQPPV input where required
• Provide PV training to local affiliate staff and third parties as required
• Maintain oversight of ongoing studies conducted in the country
• Represent Global Patient Safety in local cross-functional teams and act as the GPS point of contact at the affiliate
  
  

• Pharmacist or physician with a valid Israeli license
• Experience in the pharmaceutical industry, ideally in an affiliate setting with local PV responsibility
• Knowledge of Israeli and EU PV regulations
• Fluent in Hebrew and English (written and spoken); additional languages are an asset
• Strong leadership, project management, and strategic thinking skills
• Excellent communication, problem-solving, and organizational abilities
• Proven ability to work effectively across multicultural and cross-functional teams