Organon - Pharmacovigilance & Regulatory Affairs Specialist (BB-198B4)
Trouvé dans: Neuvoo BE
As a Pharmacovigilance (PV) and Regulatory Affairs (RA) Specialist you will be responsible for all PV and RA submission requirements and PV activities for assigned product portfolio as applicable. You will collaborate with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight. You will be also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies. You will report directly to the PV and RA Country Lead.
Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations. He/she also performing ICSR acknowledgments and reconciliation activities.
Responsible for execution of local PV and RA processes and activities in alignment with PV and RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards
Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable
Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
Supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
Supports training of the local company staff, distributors, vendors, business partners including training documentation.
Health, life science, or medical science degree or equivalent by education
Minimum of 2 years of industry experience in in pharmacovigilance and regulatory affairs
Must have a general knowledge of PV/RA regulations within his/her assigned country and be an expert in PV & RA processes/activities.
Good communication and time management skills
Fluent in English and Dutch (written and spoken)
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
A competitive salary;
32 vacation days;
Incentive Plan (bonus);
Health insurance plan;
An excellent pension;
Free use of gym;
Different training modules.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
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