Pharmacovigilance Analyst

PharmaLex Spain S.L.U.; Brasil; À distance; BRL 120 000 - 180 000; Plein temps

Résumé du poste

Cencora is seeking a Pharmacovigilance professional to oversee the local PV system and ensure compliance with applicable laws. You will manage ICSRs, screening and audits while coordinating with global PV teams and local departments.

The role requires a life sciences degree, 3+ years in PV, and strong communication skills in English and Spanish. Affiliation with PharmaLex Spain S.L.U. is noted and full-time employment is offered.

Qualifications

• University degree in Life Science; 3+ years in pharmacovigilance.
• Knowledge of regulatory guidelines for pharmacovigilance and compliance.
• Experience coordinating internal and external stakeholders.

Responsabilités

• Maintain oversight of local PV system to ensure compliance with local laws and regulations.
• Local ICSR management and PV intelligence screening.
• Participate in PV-relevant audits and inspections; provide monthly PV status reports.
• Ensure PV training for affiliate employees, service providers and third parties.

Connaissances

Leadership

Training

Communication

Stakeholder management

English

Spanish

Formation

University degree in Life Science

Regulatory affairs certification

Description du poste

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

• Maintain oversight of local PV system to ensure compliance with national laws and regulations.
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local
• Organized Data Collection
• Local PVA Management
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties
• Close cooperation with the global PV system of the client as well as related global and local departments and functions
• Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures

Experience and Educational Requirements

• University degree in Life Science
• At least 3 years’ experience in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance

Minimum Skills, Knowledge and Ability Requirements

• Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
• Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client’s team lead level.
• Good communication skills (written and verbally); capability to communicate issues and propose solutions.
• English business fluent Spanish business fluent (nice to have).
• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.
• 3+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.
• Certification in regulatory affairs, quality management, compliance, auditing preferred.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies: PharmaLex Spain S.L.U.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.

Who we are

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.