PV Specialist - 180

We are seeking a highly motivated PV Specialist with proven experience in pharmacovigilance and exceptional management skills. In this role, you will be responsible for efficiently managing interactions with the pharmacovigilance vendors, updating SOPs, overseeing safety reports, and ensuring strict compliance with all regulatory requirements. Join our team and play a key role in our company.

Responsibilities:

• Day-to-Day interactions with the pharmacovigilance vendor and following all the activities and deliverables required from the pharmacovigilance vendors.
• PSMF periodically update by MediWound as required and interactions with the PhV vendor for signing-off each periodical PSMF.
• Monthly operational report completion according to the relevant activities performed by Mediwound and their signing-off.
• Implementation of the pharmacovigilance audit strategy, and annual audit plan, and organizing pharmacovigilance audits conducted and received by MediWound, including auditor selection, approval of audit reports, authoring and follow-up of CAPAs, and approval of contractors.
• CAPAs implementations and following deviations relating to MediWound’s pharmacovigilance activities.
• Authoring and updating pharmacovigilance SOPs according to the up-to-date regulations and requirements as well as the JOG (Joint Operating Guidelines which includes the interface with pharmacovigilance vendor.
• Responsibility on Safety Data Exchange Agreements (SDEAs) to ensure they are adequate, inclusive of all bilateral requirements, and created and signed-off on time with all relevant parties.
• Pharmacovigilance training of MediWound’s staff, based on the training plan, and managing training documentation.
• Reviewing regulatory intelligence surveillance results, address all required updates from those results related to pharmacovigilance, and interact with other MediWound departments for their action as relevant.
• preparations of periodical safety reports (PBRERs, DSUR) and have an oversight on their submissions.

Requirements:

• Bachelor’s degree in pharmacy - a must.
• Minimum of 2 years of experience working in the pharmaceutical industry in pharmacovigilance/ regulatory affairs or similar position.
• Fluent in English, with excellent verbal and written communication skills.
• Demonstrated ability to effectively manage projects, ensuring timely completion of milestones and deadlines.
• Proficient in office skills and software applications