Merck Healthcare

2 Jobs

6,512 Employees

About the Company

Life is a beautiful gift and health is what allows us to enjoy it. That is why we are deeply committed to helping patients. No matter how complex or rare the disease may be, we don't give up. Our ~17,800 Healthcare employees wake up every day motivated by our purpose: To help create, improve and prolong lives - as one for patients. We are the Healthcare business of Merck, and the only pharmaceutical company that is developing solutions along the whole "circle of life". For over 350 years, patients have always been at the heart of everything we do. Our pioneering work in cancer treatment is focused on discovering, developing and delivering science-driven breakthrough therapies that turn cancer patients into cancer survivors. Our tireless passion for R&D as well as a creative and focused approach help accelerate innovation in oncology and immuno-oncology. To realize our ambition, we've created a balanced portfolio. Our core business helps provide a strong foundation, fund innovation and mitigate risks. Our specialty portfolio enables us to be on the frontlines of change and truly become a specialty innovator. We have a proud history of advancing care in immunology for people living with chronic progressive diseases such as multiple sclerosis. For more than two decades we have maintained our commitment to delivering innovative solutions across treatment, devices, and support services. This dedication drives the research and development of our pipeline products and our efforts to address areas of unmet medical need. Today, we are a global market leader in the field of fertility treatments. Our therapeutic portfolio, devices and advanced fertility technologies have helped many couples achieve their dream of having a baby. Everyone should have the opportunity to become a parent. To date, more than 5 million babies have been brought into the world with the help of our leading fertility products. Imprint: merckgroup.com/imprint Not intended for US & CA visitors.

Listed Jobs

Company Name: Merck Healthcare
Job Title: Regulatory & Safety Manager (RIP qualified)
Job Description: **Job Title** Regulatory & Safety Manager (RIP qualified) **Role Summary** Serve as the local business partner for regulatory and pharmacovigilance (PV) functions. Manage the full product lifecycle, including renewal of marketing authorisations (MA) and registration of new compounds. Act as the primary liaison with Belgian health authorities and coordinate PV activities within the Patient Safety Center BeNeLux, ensuring compliance with local and EU GVP requirements. **Expectations** - Maintain current and future marketing authorisations for the product portfolio. - Ensure regulatory compliance and timely interaction with health authorities. - Oversee PV reporting, risk management, and documentation. - Foster cross‑functional collaboration with QA, Medical Affairs, Market Access, and other business units. - Support early‑access programmes and other regulatory initiatives. **Key Responsibilities** 1. **Marketing Authorisation Management** – Renew, amend, and consolidate MA dossiers; coordinate with internal stakeholders for submission and approval. 2. **New Product Registration** – Prepare and submit registration dossiers for new active ingredients, including early‑access programmes. 3. **Health Authority Liaison** – Serve as the designated contact point for all regulatory inquiries and meetings with Belgian authorities. 4. **Pharmacovigilance Coordination** – Process individual case safety reports (ICSRs); maintain PV documentation; act as the nominated PV person to the Belgian Health Authority. 5. **Cross‑Functional Collaboration** – Work closely with QA, Medical Affairs, Market Access, and global regulatory teams to align on regulatory strategy and risk mitigation. 6. **Documentation & Reporting** – Maintain essential PV system records; report regulatory activities to the regulatory organization and Patient Safety Center Manager. **Required Skills** - In‑depth knowledge of Belgian and EU regulatory frameworks, including GVP. - Experience with pharmacovigilance systems and risk management. - Strong analytical and strategic thinking for developing mitigation plans. - Excellent written and verbal communication in English and Dutch; additional language skills a plus. - Ability to work independently and as part of cross‑functional teams. - High level of dedication, integrity, and commitment to patient safety. **Required Education & Certifications** - Master’s degree in Pharmacy or a Medical Doctor (MD). - Certified Responsible Person for Information and Publicity (RIP). - Minimum 3–5 years experience in the pharmaceutical industry with demonstrated regulatory and PV responsibilities. ---

Hoeilaart, Belgium

On site

02-11-2025

Company Name: Merck Healthcare
Job Title: Senior Manager, Central Data Monitor
Job Description: Job Title: Senior Manager, Central Data Monitor Role Summary: Lead risk signal identification and communication for clinical studies, ensuring data integrity and compliance with ICH GCP and regulatory standards. Collaborate with cross‑functional teams to develop study plans, analyze data trends, facilitate risk review meetings, and monitor corrective actions. Oversee quality checks, drive continuous improvement of central data monitoring processes, and provide leadership in multi‑project environments. Expactations: Deliver timely, accurate risk assessments; maintain high data quality and regulatory compliance; manage multiple concurrent monitoring projects; communicate findings clearly to stakeholders; demonstrate strong analytical, problem‑solving, and leadership skills; support continuous improvement initiatives in monitoring workflows. Key Responsibilities: - Develop and refine central data monitoring plans and procedures. - Identify and communicate risk signals through data trend analysis. - Participate in risk review meetings and support decision‑making. - Monitor implementation of corrective and preventive actions. - Conduct quality checks to ensure compliance with industry regulations. - Collaborate with clinical data management, site monitoring, and risk quality teams. - Drive process improvements and share best practices. Required Skills: - 7+ years in central data monitoring, with experience in clinical data management, site monitoring, or risk quality management. - Strong knowledge of ICH GCP and regulatory requirements. - Proficiency in data visualization and risk‑based monitoring tools (e.g., CluePoints). - Advanced MS Office skills. - Excellent analytical, problem‑solving, and project management abilities. - Effective communicator with leadership capabilities. - Detail‑oriented, results‑driven mindset. Required Education & Certifications: - Advanced degree (Master’s or PhD) in Life Sciences or related field. - Demonstrated knowledge of ICH GCP and clinical trial regulations.