At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Job Title: Director/Sr. Director Drug Safety & Pharmacovigilance
Job Location: Bridgewater, NJ
• Lead the establishment of the Drug Safety and Pharmacovigilance department for Dr. Reddy’s in the U.S.
• Serve as the corporate subject matter expert for Dr. Reddy’s for all U.S. drug safety and pharmacovigilance regulations and requirements and align with global pharmacovigilance activities and team of Dr Reddy's as an organization
• Recruit, train, manage and mentor the service provider or outsourced partner on Dr Reddy's pharmacovigilance processes
• Develop and implement appropriate SOPs and processes for the drug safety and pharmacovigilance department
• Provide oversight and guidance to the timely preparation of pharmacovigilance reports for submission to the FDA, including 15-Day Alert Reports and Periodic Safety Reports and update regional safety information to support company core safety information (CCSI)
• Have a sound understanding of quality control methods in pharmacovigilance, with an experience of developing team member/s on same.
• Coordinate with global team to develop local methods of signal detection
• Work closely with the Regulatory Affairs, Quality Assurance, Clinical Development, and other departments on ensuring regulatory requirements for clinical and marketed products are satisfied with respect to drug safety monitoring and pharmacovigilance
• Manage the implementation, validation, and roll-out of a drug safety database for use in the U.S.
• Establish, review and maintain pharmacovigilance agreements (adverse event exchange agreements) with partner companies
• MD, PharmD, PhD is relevant scientific discipline with certified training in pharmacovigilance from a recognized institute or university
• A minimum of 10 years experience in drug safety and pharmacovigilance including 3 years of team lead experience in pharmacovigilance, within the pharmaceutical industry
• Thorough knowledge of US and EU drug safety regulations and requirements for marketed and investigational products; knowledge of Medical Device reporting desirable
• Demonstrated leadership skills with a proven record of establishing and managing a pharmacovigilance department
• Experienced with coding in MedDRA, WHO and other relevant product dictionaries
• Experienced with the implementation and detailed use of a major safety database (experience with ARISg preferred), having handled and monitored ADR processing activity from point of data entry till medical evaluation & reporting
• Excellent verbal and written communication, organizational, and time management skills
From unsurpassed career momentum to our innovative perks and benefits, we do everything we can to make sure our employees not only do exceptional work, but have exceptional rewards, as well. If you are committed to making a profound impact worldwide, we invite you to learn more about our career opportunities, our products, and our plans for the future. Please visit us at www.drreddysusjobs.com.
Please Note: We are a corporate office and not a doctor’s office.
We will not accept any calls or other inquiries from recruiters for this position.
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