Drug Safety Associate

2 weeks ago

Princeton, United States Sun Pharmaceutical Industries Full time

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE

* Hybrid work arrangement
* Medical, Dental, Vision Benefits
* Health Savings Account (HSA), Flexible Spending Account (FSA)
* Prescription Drug Coverage
* Telehealth and Behavior Health Services
* Income Protection - Short Term and Long Term Disability Benefits
* Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
* Group Life Insurance
* Wellness Programs
* Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

DOWNLOAD OUR CODE OF CONDUCT

The Drug Safety Associate is responsible for assigned Sun Pharma Risk Evaluation and Mitigation Strategy (REMS) programs and for other Pharmacovigilance activities as detailed below.

The responsibilities of this role include, but are not limited to the following:

* Participate in REMS meetings and manage the development, implementation and/or maintenance of REMS
* Timely escalate issues related to vendor performance, compliance and/or budget to manager
* Ensure timely execution of operational aspects of REMS and related activities
* Review all REMS related documentation and approve as required.
* Monitor external environment for regulatory changes impacting Pharmacovigilance and risk management
* Ensure audit preparedness and support regulatory inspections
* Identify and lead process improvement activities
* Assist with regulatory submissions
* Assist with performing follow ups for ADEs as required
* Support training management
* Support compliance driven initiatives

Qualifications

* Bachelor's degree preferably in a scientific discipline.
* 1 - 3 years of experience in Pharmacovigilance within the pharmaceutical industry with experience in REMS or other risk management strategies preferred
* Experience managing a vendor (e.g. CRO, REMS administrator) and managing project timelines

Skills

* Excellent interpersonal skills and effective communication skills
* Adapts to changing circumstances and effectively prioritizes workload according to business need
* Ability to multi-task and manage projects simultaneously assuring compliance
* Working knowledge of FDA, Health Canada and/or EMEA regulations/guidance/guidelines with respect to Pharmacovigilance and REMS
* Proficient is Microsoft Word, Excel, PowerPoint, SharePoint, and Abode Acrobat

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