Drug Safety Specialist

In a few wordsPosition :

Drug Safety Specialist (maternity leave)Location :

MadridWant to know more?INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.The activities of INSUD PHARMA are organized into three synergistic business areas :

Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.Ready to be a #Challenger?What are we looking for?As a member of the Patient Safety & Risk Mitigation area within the Corporate Pharmacovigilance and Drug Safety Department of Insud Pharma, you will provide maternity leave cover as Drug Safety Specialist.The main responsibility is to support the maintenance of a globalized Pharmacovigilance (PV) system, with a particular focus on the preparation and writing of aggregate reports including, Renewals, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP and ad hoc HA requirements. You will collaborate closely with pharmacovigilance teams across different business units to ensure high-quality safety documentation and regulatory compliance. This position offers an opportunity to analyze risks of medical products from the perspective of their benefits to patients and the society.The challenge- Prepare, review, and notify aggregated safety reports (PSURs / DSURs) and Risk Management Plans (RMPs) to Health Authorities under supervision.- Collaborate on medical queries related to Pharmacovigilance activities.- Contribute to the maintenance and execution of the Global Signal Detection process for Insud Pharma.- Ensure the timely and accurate preparation of safety documents in compliance with regulatory requirements and company standards.- Work closely with cross-functional teams (Regulatory Affairs, Medical, Legal, Marketing, Commercial) to collect relevant data and ensure consistency in safety documentation.- Participate in global medical literature monitoring and the review of web pages and media relevant to Pharmacovigilance activities.- Monitor medical literature, the global safety database, and the EudraVigilance database for signal detection and management activities.- Support the maintenance of a robust Quality Pharmacovigilance System within the Patient Safety & Risk Mitigation area.- Assist in responding to Health Authorities regarding safety documentation as required.- Contribute to the continuous improvement of safety writing processes and templates.- Maintain Pharmacovigilance files in a safe, accurate, up-to-date, and complete manner, in compliance with internal standards and applicable regulations.What do you need?- Education :

University Degree in Health Sciences (Pharmacy, Medicine, Odontology). In case of Biology, Biotechnology, etc., it shall be necessary a Health Science orientation.- Languages :

Fluent Spanish and English.- Experience (years / area) :

At least 4 years of experience in Pharmacovigilance and Drug Safety.- Specific Knowledge :

Candidate must demonstrate knowledge with signal detection and risk management in accordance with GVP. Deep knowledge of the current European PV Legislation and ICH / Regulation. Knowledge and management of electronic PV databases such as Argus.- Personal skills :

• Entrepreneurial, analytical skills, adaptability / flexibility, initiative, sociable and responsible.Our benefits1. Flexible start time from Monday to Friday (full-time 40 hours).2. Life and accident insurance.3. Ticket Restaurant.4. Co-payment in voluntary health insurance.5. Benefits and Savings Club.6. Development plans, internal mobility policy.7. Many moreWhat 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 twointerviews 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?Follow us on social media like LinkedIn / Instagram and stay tuned for any offers we may release;

the opportunity to be anew Insuder is waiting#InsudPharma #Challenger #Insuder #InsudTalentCOMMITMENT TO EQUAL OPPORTUNITIESThe InsudPharma group 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.