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