Position: Quality Specialist for Global Pharmacovigilance & Drug Safety
Location: Madrid.
Experience: +5 years industrial experience in either pharmacovigilance or in a QA department interfaced with pharmacovigilance and clinical operations. A proven track-record for the performance of audits, preferably GVP/GCP.
Want to know more? 👇
#InsudPharma operates across the entire pharmaceutical industry value chain, offering expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products for human and animal care, as well as biopharmaceuticals for the treatment and prevention of diseases across various therapeutic areas.
With over 45 years of experience, we have become an established global group in the pharmaceutical industry, with continuous growth and diversification, and with quality at the heart of everything we do. Insud Pharma is present at all levels of the chemical-pharmaceutical industry through Chemo, Exeltis, and mAbxience.
#OneHealth
Ready to be a #Challenger?
What are we looking for? 🔎
We are searching for a Quality Specialist to maintain and assist the EU QPPV with the development of the Quality Management System for Global Pharmacovigilance in the individual business units of Insud Pharma.
The challenge!
* Take responsibility of the audit plan in collaboration with the EU QPPV for the business units of InsudPharma.
* Performance of audits and qualifications and periodic follow-ups of service providers, business partner and commercial suppliers.
* Establish, improve and maintain the Global QMS system (SOPs, Policies, Guidance’s and WIs) on behalf of pharmacovigilance for the business units in InsudPharma.
* Assist in the handling of partner audits, CAPA resolutions, deviations, complaints and change control procedures
* Assist the EU QPPV with the periodic measurements of the performance of the quality management system (metrics)
* Provide support as requested in the maintenance of the Pharmacovigilance System Master File (PSMF) and the pharmacovigilance surveillance activities in place for monitoring patient safety for marketed products.
* Establish and maintain collaborations with other departments and business units in Insud Pharma, affiliates and business partners to ensure a consistent interpretation and effective implementation of quality standards.
* Provide quality assurance support as requested to the function for clinical operations and the execution of interventional clinical studies conducted under GCP.
* Collaborate with Insud Pharma’s PV teams as requested to ensure the quality standards for global pharmacovigilance departments fulfil the regulations described in ICH guidance’s and fulfil standards described for GVP, GCP or local laws in collaboration with the EU QPPV.
* Attend relevant conferences and scientific meetings to stay updated with emerging law, regulations and guidelines and assure process compliance with applicable guidelines and standards for safety reporting.
* Provide support and guidance on the choice of service providers and IT solutions to support pharmacovigilance processes.
* Provide support to ensure an effective and cooperative cross-functional teamwork at the local, regional, and global levels.
What do you need?
* Education: Science degree.
* Languages: Fluent in English; intermediately in Spanish.
* Experience (years/area): +5 years industrial experience in either pharmacovigilance or in a QA department interfaced with pharmacovigilance and clinical operations. A proven track-record for the performance of audits, preferably GVP/GCP
* Specific Knowledge: In-depth knowledge of ISO 9001:2015, GVP and/or GCP.
* Travels: Willing to travel
* Personal skills: Initiative and proactivity, ability to make decisions autonomously, decisiveness, people management skills, sense of responsibility, excellent communication skills.
Our benefits!
* Flexible start time from Monday to Friday (full-time 40 hours).📜
* Permanent contract.💸
* Attractive salary package.🥼
* Life and accident insurance.🍽
* ️ Company cafeteria (free).🥼
* Co-payment in voluntary health insurance.💸
* Benefits and Savings Club.📈
* Development plans, internal mobility policy.⭐
* Many more!
What will the Selection process be like? ??️
➡Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.
➡Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.
➡Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.
Do you think this offer is not for you?
Apply now!!
#InsudPharma #Challenger #Insuder #InsudTalent
COMMITMENT TO EQUAL OPPORTUNITIES
Insud Pharma is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.