Local Pharmacovigilance Specialist

PharmaLex; Madrid; A distancia; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical service provider in Madrid is seeking a Local Pharmacovigilance Specialist to manage pharmacovigilance systems. The candidate should have 1-2 years of experience and be fluent in Spanish and English. This is a remote position, offering opportunities for professional growth and a collaborative work environment.

Formación

• 1-2 years experience within pharmacovigilance.
• Fluency in both Spanish and English.

Responsabilidades

• Set up and manage the local pharmacovigilance system.
• Ensure PV training of affiliate employees and service providers.
• Participate in PV-relevant audits and inspections.

Conocimientos

Business and financial acumen

Analytical and mathematical skills

Effective oral and written communication

Interpersonal and leadership skills

Organizational skills and attention to detail

Deadline management capabilities

Problem-solving skills

Presentation skills

Descripción del empleo

Join to apply for the Local Pharmacovigilance Specialist role at PharmaLex

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.

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

Pharmalex is recruiting for a talented Pharmacovigilance & Medical Information Specialist to join our team in Spain! We are looking for a fluent Spanish speaker with 1-2 years experience as a Pharmacovigilance Specialist/Drug Safety Associate who will be dedicated to our world-class pharmaceutical partner's project. This is a remote-based position that can be hired in Spain.

Responsibilities

• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• 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
• Address Medical Information requests (MIR) from multiple programs and sources using approved responses

Experience

• 1-2 years experience within pharmacovigilance
• Fluency in Spanish and English

Skills

• Strong business and financial acumen
• Strong analytical and mathematical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal and leadership skills
• Effective organizational skills, attention to details
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Excellent presentation skills

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.

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].