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Expert - Clinical Safety Operations (Project & Program Mgmt., Global customers/ stakeholders, Vendor
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
BANGALORE HIRING for Expert - Clinical Safety Operations
(Project & Program Mgmt., Global customers/ stakeholders, Vendor Mgmt.)
The role of the Expert – Clinical Safety Operations is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational clinical safety aspects. This includes the provision of key expertise and guidance to concerned Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks.
In addition, the Expert – Clinical Safety Operations is accountable for the development, optimization, implementation, and documentation of appropriate processes to ensure pharmacovigilance compliance in the area of responsibility. Define process KPls, implement, monitor, and communicate performance and develop solutions for continuous improvements.
Ensures Merck required compliance by vendors involved in clinical trials and non-interventional post authorization studies in close collaboration with the Vendor Manager.
The Expert - Clinical Safety Operations is responsible and accountable for:
- Contribute to and oversee safety aspects on EAC, CU programs.
- Standard operating procedure (SOPs), Working Instructions (WI) reviews, inputs, knowledge, and understanding.
- Review Informed Consent Form (ICF) and input for safety related sections.
- Review Protocol for safety related sections.
- Review Investigator sponsored studies (ISS) agreement.
- Setup and manage Early Access Program (EAP) and Compassionate Use (CU).
- Contribute to Request for proposal reviews and Vendor Selection.
- Contribute to defining and implementing clinical trial safety related activities in the Alliance with relevant partners/service providers of Merck and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes.
- Responsible for Safety Management Plan SMP), including review and oversight.
- Maintenance of Reference Safety Information (RSI).
- Oversight on Safety Monitoring Committee (SMC)/ Data Monitoring Committee (DMC) Coordination of activities.
- Review of Electronic Case Report Form (eCRF) for safety related sections.
- Oversight on Serious Adverse Event (SAE) and ISS reconciliation.
- Oversight on Query management within Common Communication Module (CCM tool).
- Act as a subject matter expert (SME) for COMPASS database.
- Review Electronic Trial Master File (eTMF) for safety relevant core documents.
- Contribute to Trial Oversight Plan (TOP) for safety relevant sections.
- Contribute to the improvement of routine pharmacovigilance activities throughout the process lifecycle.
- Liaise between internal/ external stakeholders as needed.
- Contribute during audits and inspections as assigned. Liaise with Quality Assurance for completion of CAPA plans.
- Work closely with internal and/ or external partners to manage development, testing, and use of electronic systems necessary for CSO processes.
- Apply expertise in aligned areas and mentor developing specialists, less experienced, or newer staff members.
- May provide oversight role on operational and collaborative tasks as directed by manager or Head of Clinical Safety Operations.
- Participate in team meetings and provide regular feedback on operations, issues, and successes.
- Contribute to the achievement of departmental goals.
- Ensure all required training is executed within the stipulated period.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html