Phibro Animal Health
Pharmacoviligance Operations Manager - PV
Phibro Animal Health, Teaneck, New Jersey, United States
Overview
Pharmacovigilance Operations Manager - PV role at Phibro Animal Health. The Pharmacovigilance (PV) Operations Manager is an integral part of the Management team based out of US - Teaneck, NJ - Remote site. Compensation range for this position is $100,800.00 - $120,000.00. The PV Operations Manager is responsible for activities related to the management of PV cases received globally, in accordance with applicable regulations. He/she maintains the global PV database, participates in the development and maintenance of the PV system in compliance with international regulations for Phibro products (Veterinary Medicinal Products and feeding stuffs) in particular US, Canadian and European regulations, and collaborates with the PV Manager/Deputy QPPV in case evaluation. Responsibilities
Global PV system: Manage processing of incoming data, ensure information is processed, tracked, entered and coded in the PV database according to Phibro PV standards; ensure full documentation of individual case safety reports in the PV database. Serve as the Phibro representative for SafetyCall activities: maintain/update the product list and product information package; review individual case safety reports originating from USA and Canada. Guarantee submission and acknowledgement of PV cases per defined reporting requirements; create and maintain a reporting matrix for Phibro products. Identify and enter authorities’ cases in Health Authorities databases according to Phibro PV standards. Ensure reconciliation with partners in accordance with PV standards and SDEA/PV agreements. Contribute to maintenance and development of PV regulatory knowledge; provide methodological review and support on case entry and regulatory submissions. Key Responsibilities Continued – PV Database
Maintain validation of the PV database through periodic reviews and VedDRA dictionary version upgrades, with support from the PV database supplier. Oversee day-to-day follow-up of database incidents; ensure proper user training, access configuration and monitoring. Ensure coherence and homogeneity of data; conduct regular reviews and define action plans as needed. Manage relations with the PV database supplier with support from the Global PV Manager. Key Responsibilities Continued – Benefit/Risk, Signal Detection, Risk Management
Participate in ongoing safety review through case reviews; inform the Global PV Manager of any alerts identified. Ensure availability of requests (periodic summaries, signal detection, or evaluations from authorities) as needed. PV Quality System and KPIs
Maintain and develop the PV quality system related to PV operations. Implement and monitor key performance indicators for PV operation activities; contribute to audit and inspection readiness with the Global PV team. Key Competencies / Qualifications
B.S. degree in Life Sciences or equivalent experience. More than 3 years of industry experience in a compliance role, preferably in pharmacovigilance/patient safety. Knowledge of global regulatory requirements for pharmacovigilance of veterinary medicinal products. Knowledge of guidelines and regulations governing Animal Health at local and international levels. Ability to collaborate across disciplines and nationalities; strong time and quality management; initiative and persistence. Good judgement, project management and priority-setting skills. About Phibro
Phibro Animal Health Corporation is a publicly traded, global organization in animal health and nutrition. We provide solutions to help maintain and enhance animal health, with revenues over $1 billion and over 2,400 employees worldwide. Location & Schedule
Location: US - Teaneck, NJ - Remote Work Schedule: Monday - Friday (Standard Work hours). Equal Opportunity
Phibro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.
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Pharmacovigilance Operations Manager - PV role at Phibro Animal Health. The Pharmacovigilance (PV) Operations Manager is an integral part of the Management team based out of US - Teaneck, NJ - Remote site. Compensation range for this position is $100,800.00 - $120,000.00. The PV Operations Manager is responsible for activities related to the management of PV cases received globally, in accordance with applicable regulations. He/she maintains the global PV database, participates in the development and maintenance of the PV system in compliance with international regulations for Phibro products (Veterinary Medicinal Products and feeding stuffs) in particular US, Canadian and European regulations, and collaborates with the PV Manager/Deputy QPPV in case evaluation. Responsibilities
Global PV system: Manage processing of incoming data, ensure information is processed, tracked, entered and coded in the PV database according to Phibro PV standards; ensure full documentation of individual case safety reports in the PV database. Serve as the Phibro representative for SafetyCall activities: maintain/update the product list and product information package; review individual case safety reports originating from USA and Canada. Guarantee submission and acknowledgement of PV cases per defined reporting requirements; create and maintain a reporting matrix for Phibro products. Identify and enter authorities’ cases in Health Authorities databases according to Phibro PV standards. Ensure reconciliation with partners in accordance with PV standards and SDEA/PV agreements. Contribute to maintenance and development of PV regulatory knowledge; provide methodological review and support on case entry and regulatory submissions. Key Responsibilities Continued – PV Database
Maintain validation of the PV database through periodic reviews and VedDRA dictionary version upgrades, with support from the PV database supplier. Oversee day-to-day follow-up of database incidents; ensure proper user training, access configuration and monitoring. Ensure coherence and homogeneity of data; conduct regular reviews and define action plans as needed. Manage relations with the PV database supplier with support from the Global PV Manager. Key Responsibilities Continued – Benefit/Risk, Signal Detection, Risk Management
Participate in ongoing safety review through case reviews; inform the Global PV Manager of any alerts identified. Ensure availability of requests (periodic summaries, signal detection, or evaluations from authorities) as needed. PV Quality System and KPIs
Maintain and develop the PV quality system related to PV operations. Implement and monitor key performance indicators for PV operation activities; contribute to audit and inspection readiness with the Global PV team. Key Competencies / Qualifications
B.S. degree in Life Sciences or equivalent experience. More than 3 years of industry experience in a compliance role, preferably in pharmacovigilance/patient safety. Knowledge of global regulatory requirements for pharmacovigilance of veterinary medicinal products. Knowledge of guidelines and regulations governing Animal Health at local and international levels. Ability to collaborate across disciplines and nationalities; strong time and quality management; initiative and persistence. Good judgement, project management and priority-setting skills. About Phibro
Phibro Animal Health Corporation is a publicly traded, global organization in animal health and nutrition. We provide solutions to help maintain and enhance animal health, with revenues over $1 billion and over 2,400 employees worldwide. Location & Schedule
Location: US - Teaneck, NJ - Remote Work Schedule: Monday - Friday (Standard Work hours). Equal Opportunity
Phibro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.
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