Head Pharmacovigilance & Medical Affairs

Company Description

dy's "Good Health Can't Wait"
By joining Dr. Reddy's, 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.

Diversity, Equity & Inclusion
dy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Job Description

We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's North America Generics and affiliates as well as Dr. Reddy's Canada. Incumbent will drive Medical Affairs strategies and be responsible for accurate patient safety data. Provide oversight on medical information services and support in providing strategic inputs to cross functional teams as well as initiate, improve and monitor the execution of existing systems.

Responsibilities:

• Manage, create (vendor) and review ICSR (US/Foreign), PSR reports from clinical and medical standpoint, identify and respond to signal analysis, and submit to regulatory agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm
• Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in audits and provide support in external audits. Responsible for driving successful PV audits to achieve no critical findings and provide post inspection report with corrective action plan
• Identify pharmacovigilance processes and procedures to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements
• Review current reporting period against historical data to conduct detail evaluation of risks / identify potential risk areas. Review existing products for safety risks and generate report on product risk-benefit ratio and develop proposal for regulatory agencies and manage the REMS program, budget and ensure regulatory sign off and take corrective actions when necessary
• Support in the development and execution of North America Medical Affairs plans and Dr. Reddy's Canada Medical Affairs plans in consideration of best clinical practices and overall corporate objectives aligned with commercial Brand strategy
• Provide oversight of the medical information services for North America and ensure seamless communication with Pharmacovigilance service providers
• Engage effectively cross-functionally, maximizing functional reporting relationships, and ensure successful implementation of company strategies. Support scientific congress attendance via pre-meeting planning and post-meeting CI reporting
• Support global Pharmacovigilance digitalization efforts to increase efficiency, quality & productivity while ensuring that the deliverables are 21
  
  CFR Part 11, GAMP 5 and GxP compliant

Incumbent should be willing to work in person from our Princeton, NJ office

Qualifications

Educational qualification: Advanced scientific degree (MD, PhD, Pharm.

D. or other)

Minimum work experience: 10+ years in PV & Medical Affairs in the pharmaceutical industry

Skills & attributes:

• Understanding of North American pre-and post-marketing regulatory requirements for medical Affairs and Medical Information activities.
• Knowledge of FDA and Health Canada:
  Drug Discovery and Development Processes;
  Clinical Development Tools and Processes;
  Medical Affairs Guidelines;
  Regulatory Guidelines;
  Pharmacovigilance Guidelines;
  Domains across the pharma value chain
• A collaborative team player with ability to work successfully across teams and functions
• Proactiveness with attention to detail
• Excellent communication skills (verbal & written); MS Office suite
• Demonstrated ability to manage various projects, solve problems,…