Career Opportunities: Pharmacovigilance & Drug Safety Specialist (Temporary) (4304)

Bial; Porto; Presencial; EUR 35 000 - 50 000; Tempo integral

Resumo da oferta

A global pharmaceutical company is seeking a Pharmacovigilance & Drug Safety Specialist for a temporary position to cover maternity leave. The role involves collaborating on the Pharmacovigilance network, evaluating the safety of medicinal products, and ensuring compliance with Good Pharmacovigilance Practices. The ideal candidate will have a degree in Pharmaceutical Sciences and solid knowledge of GVP, along with excellent planning and communication skills.

Qualificações

• Degree in Pharmaceutical Sciences or similar areas.
• Solid knowledge of Good Pharmacovigilance Practices.
• Previous experience in GVP audits and inspections.
• Advanced IT skills.
• Very good planning and organization skills.
• Assertiveness and good communication and interpersonal skills.
• Knowledge of epidemiology and biostatistics (preferred).

Responsabilidades

• Collaborate in the establishment of a Pharmacovigilance network.
• Contribute towards safety information management systems.
• Collaborate on evaluation of product safety.
• Support assessment of quality defects impacting safety.
• Collaborate on training for Pharmacovigilance procedures.
• Ensure collection and assessment of adverse reactions.
• Understand safety profiles of BIAL medicinal products.
• Ensure prompt responses to authority information requests.
• Contribute towards quality management systems.

Conhecimentos

Good Pharmacovigilance Practices

Planning and organization

Communication and interpersonal skills

Advanced IT skills

Formação académica

Degree in Pharmaceutical Sciences or similar

Descrição da oferta de emprego

Career Opportunities: Pharmacovigilance & Drug Safety Specialist (Temporary)

Reporting to the Senior Director, Pharmacovigilance & Drug Safety, the Pharmacovigilance & Drug Safety Specialist collaborates in implementing and within the management of Bial Pharmacovigilance and Drug Safety system during clinical development, post authorization and commercialization phases, in compliance with the applicable legislation.

Join Our Mission to Improve Lives Worldwide

The Impact You’ll Make

• Collaborate in the establishment of a Pharmacovigilance network of Bial in all countries where the company operates and in the exchange of drug safety information with affiliated companies, service providers, distributors and partners;
• Contribute towards the safety information management systems and to the monitoring of defined plans;
• Collaborate on the evaluation of product safety (e.g., PSURs - Periodic Safety Update Reports);
• Support the assessment of quality defects and quality issues with the potential safety impact;
• Collaborate in the training on the Pharmacovigilance procedures of the Bial;
• Contribute towards the management of the system that ensures that all suspected adverse reactions reported to BIAL are collected and assessed so that they are available in at least one point in the European Union;
• Understand the safety profiles and concerns regarding BIAL medicinal products;
• Collaborate to ensure a prompt and comprehensive response to any request for information performed by the authorities regarding necessary information for the benefit-risk assessment of BIAL medicinal products;
• Contribute towards quality management system regarding Good Pharmacovigilance Practices that includes quality assurance and quality control procedures, compliance monitoring, SOPs, training and audits.

What You’ll Bring

• Degree in Pharmaceutical Sciences or similar areas;
• Solid knowledge of Good Pharmacovigilance Practices;
• Previous experience in GVP audits and inspections;
• Advanced IT skills;
• Very good planning and organization skills;
• Assertiveness and good communication and interpersonal skills;
• Knowledge of epidemiology and biostatistics (preferred).

This is a temporary position to cover a maternity leave.

We are an equal opportunities employer and welcome applications from all qualified candidates.