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Posted: Monday, January 8, 2018 9:20 AM

Description

Dr. Reddy's Laboratories, Inc.

PharmD Pharmaceutical Industry Fellowship Program 2018-2020

General Overview of Fellowship

The Dr. Reddy's Laboratories, Inc. Post-Doctor of Pharmacy (PharmD) Industry Fellowship Program is intended to provide a comprehensive global multi-disciplinary experience for PharmD graduates who desire to focus and accelerate their career within the Pharmaceutical Industry.

Fellows will have the opportunity to gain first-hand knowledge in a variety of functional areas across brand and generic drugs, devices and biosimilars. The initial focus will be Pharmacovigilance/Medical Affairs for the North American region, with exposure to other disciplines such as Quality Assurance or Regulatory Affairs. The fellow will be expected to become a fully integrated part of Dr. Reddy's Laboratories.

The fellow will report to the Global Head of Pharmacovigilance and the Head of Medical Affairs North American Generics and Canada. Responsibilities will be focused in the US and Canada. The fellow will develop a thorough understanding of the operations in Pharmacovigilance and in Medical Affairs in the US and how it differs from our other geographies.

Relationships

The fellow will report directly to the Head of Medical Affairs North America Generics and Canada and Global Head of Pharmacovigilance depending on the rotation. The fellow will interact with colleagues in Regulatory Affairs, Clinical Development, Quality Assurance, Manufacturing and Supply Chain, Information Technology, Sales and Marketing.

Responsibilities

Medical Affairs:

* Respond to medical inquiries from health care professionals, patients/consumers, and customers

* Develop scientifically accurate medical responses to unsolicited medical inquiries from Healthcare Professionals

* Create standard responses to FAQs to respond to unsolicited medical inquiries from patients and consumers

* Assist in developing claims for OTC products, including Rx-to-OTC switches

* Assist in the development, review and approval of labeling activities

* Train Medical Information Call Center staff

* Participating in the medical review of promotional and non-promotional materials

* Participate in medical slide content development and review

* Serve as a subject matter expert on the selected disease state

* Facilitate meetings

* Mentor pharmacy undergraduate interns

Pharmacovigilance:

* Develop working knowledge and practice of global drug, biosimilar and device safety rules and regulations during clinical trials

* Develop working knowledge and practice of global drug, biosimilar and device safety rules and regulation for approved products

* Develop working knowledge and practice of various validated technologies and database tools used to support Pharmacovigilance

* Become proficient at Signal Management

* Liaise with internal colleagues to interpret safety data to perform benefit: risk assessments

* Write, review and analyze individual case safety reports and aggregate safety reports

* Review study protocols and clinical trial data for Adverse Events

* Actively participate in patient registry, support programs and multi-sponsor REMS programs

* Assist in the training of adverse event reporting for new hires

Requirements

* Graduate of an Accreditation Council for Pharmacy Education (ACPE)-accredited Doctor of Pharmacy Program prior to the start date of the fellowship term

* Have a strong interest in pursuing a career in the pharmaceutical industry

* Must be a U.S. citizen or lawful permanent resident

* Demonstrated leadership capabilities

* Demonstrate excellent communication skills, both oral, written and presentation

* Strong decision making and problem solving abilities as well as excellent time management, data research and situation analysis proficiencies.

SDL2017


Associated topics: antibody, dietary, dietician, drug, food, histotechnologist, immunoassay, nephrology, nutritionist, pharmacometrics

Source: http://www.jobs2careers.com/click.php?id=4643136074.96


• Location: Jersey Shore

• Post ID: 52080467 newjersey
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