THE OPPORTUNITY
Based in Singapore, the regional hub for Asia Pacific (AP) and named one of the Best Companies to Work for in 2019 by HR Asia Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
As a Pharmacovigilance (PV) Senior Specialist, you will be responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. You will be responsible for day-to-day case management activities for your assigned product portfolio as applicable. You will collaborate with colleagues to ensure compliance with local laws and regulations, as well as adjusting schedules to support your colleagues to ensure there is no gap in adverse event reporting and drug safety oversight.
WHAT YOU WILL DO
Serves as the back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. Serves as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned). Oversees all daily PV processes and activities within the countries covered by the country operation as required. Establishes and coordinates reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations 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. Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations. Participates in and supports audits of contractual partners/vendors as necessary. Develops and maintains local PV-controlled documents (i.e., SOPs, CCPDs, training materials, etc. as applicable) ensuring that they are kept current. Assists in developing local procedures (in compliance with regional and standards) for the department, to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.Work Experience
WHAT YOU MUST HAVE
Degree in Life Science, medical science or health-related degreeDemonstrated solid pharmaceutical industry experience in Pharmacovigilance/Drug SafetyGood knowledge of PV regulations, processes and activitiesDemonstrated supervisory experience in managing people/teams/contractorsAbility to be self-motivated and able to work with processesFluent (written & oral) English communication skills with a collaborative mindsetAbility to develop good working relationshipsStrong organisational and project management skills to handle multiple tasks under time pressureProficient User of Microsoft Suite (Word, Excel)Experience working with safety databases such as ARGUS
WHAT YOU CAN EXPECT
Opportunity to have a career of purpose Work with a passionate Pharmacovigilance and Regulatory Affairs Team Work within a company that believes in making a significant impact on the health and lives of people around the world.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us — and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.
Requisition ID:P-100391