Position Details

The Pharmacovigilance (PV) Operation Manager is directly responsible for the activities related to the management of PV cases received globally, in accordance with the applicable regulations in force.
The PV Operation Manager is also responsible for maintaining the global PV database with its validation and activities related to the database.
It participates in the development and maintenance of the PV system in compliance with international regulations for Phibro product (Veterinary Medicinal Products and feeding stuffs) in particular US, Canadian and European regulations in compliance with the Phibro's PV standards. The PV operation manager in collaboration with the PV Manager -Deputy QPPV participates in the evaluation of the cases.

Key Responsibilities

Global PV system:

• Manage the processing of incoming data: ensure that all incoming information is processed, tracked, entered and coded in the PV database according to the Phibro's PV standards. Ensure full documentation of individual case safety reports in the PV database.
• Serve as “Phibro representative” for SafetyCall activities: maintain and update the product list and product information package; and ensure the review of individual case safety reports originating from USA and Canada.
• Guarantee the submission and acknowledgement of PV cases in accordance with the defined reporting requirements. Create and maintain a reporting matrix for Phibro products.
• Ensure that the Authorities’ cases are identified in the databases of the Health Authorities, entered and coded in the PV database according to the Phibro's PV standards.
• Ensure that the reconciliation process is conducted with partners in accordance with the Phibro's PV standards and the SDEA/PV agreements.
• Contribute to the maintenance and development of the level of knowledge on the regulatory requirements in PV, Phibro products by providing methodological review and support on case entry and regulatory submissions.

Key Responsibilities Continued

Global PV database:

• Ensure the maintenance of validation of the PV database through the periodic review of the database and the version upgrades of the VedDRA dictionary, with the support of the supplier of the PV database.
• Oversee the day-to-day follow-up of database incidents and the communication of information to users. Guarantee the proper training of users, the configuration and monitoring of access.
• Organize the coherence and homogeneity of the data entered in the database with the implementation of regular reviews of the database, define the associated action plans if necessary and their follow-up.
• Manage relations with the supplier of the PV database with the support of the Global PV Manager.

Key Responsibilities Continued

Benefit/Risk, Signal Detection, Risk Management:

• Participate in ongoing safety review through review of cases. Inform immediately the Global PV Manager of any alert identified through the case review.
• Ensure the availability of requests (periodic summary reports, signal detection or for any request for evaluation of a signal or in response to a question from an authority, etc.)

Maintain and develop the PV quality system in connection with the PV operations activities:

• Implement and monitor key performance indicators for PV operation activities.
• Participates with Global PV team in audit and inspection readiness activities.

Key Competencies Required

• B.S degree in Life Sciences, or equivalent work experience
• More than 3 years of industry experience in a compliance role, preferably in pharmacovigilance/patient safety.
• Sound knowledge of the global regulatory requirements concerning pharmacovigilance for veterinary medicinal products
• Knowledge of guidelines and other applicable local and international regulations governing Animal Health.
• Ability to form productive working relationships at all levels across disciplines and nationalities.
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Self-motivated decision maker with a high degree of initiative, commitment and persistence.
• Must exhibit good judgement, excellent project management and priority-setting skills.