Pharmacovigilance Associate Position at Dr. Reddy’s Laboratories – Apply before 30th July 2024

Dr. Reddy’s Laboratories

Website Dr. Reddy’s Laboratories

About Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories Ltd is a global pharmaceutical company that is focused on providing affordable and innovative medicines to improve people’s health. The company operates in three main businesses: Pharmaceutical Services and Active Ingredients, Global Generics, and Proprietary Products.

The company’s portfolio includes APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations. Dr. Reddy’s has a major therapeutic focus on areas such as gastro-intestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective.

Dr. Reddy’s serves major markets such as India, the United States, Russia-CIS, and Europe, as well as other select geographies within Emerging Markets.

Job Posting: Pharmacovigilance Associate

Job Description

Roles & Responsibilities

  • Document Drafting: Create procedural documents such as Standard Operating Procedures (SOPs), Work Instructions, and Guidance Documents to outline pharmacovigilance (PV) processes.
  • Review and Format Documents: Participate in the review, formatting, and routing of procedural documents authored by other team members.
  • Training Material Development: Assist in the creation of training materials for procedural documents, ensuring comprehension and proper documentation.
  • Training Curricula Support: Aid in developing training curricula for the global PV Team and affiliates, as applicable.
  • Adverse Event Reporting Training: Develop and deliver adverse event reporting training for non-PV internal teams and drug safety vendors on both routine and annual bases.
  • Request for Information (RFI) Compilation: Perform and compile RFI with PV data, including adverse event collection, case processing, signal and risk management, clinical studies, and PV safety concerns.
  • PADERS Submission: Handle the submission and publishing of PADERS for all DRL products and acquired products.
  • Regulatory Correspondences: Update the PV shared drive with labeling updates and communicate these to other PV stakeholders.
  • Strategic Information Provision: Ensure the provision of strategic information and complete PV due diligence for potential product acquisitions/divestitures, and creation/modification of Safety Data Exchange Agreements (SDEAs).
  • Product List Management: Maintain the North America Product List for PV oversight, including the master list and external/in-licensing products.

Secondary Responsibilities

These responsibilities will be undertaken as needed to support the global PV Team:

  • Adverse Event Triage: Receive and independently triage adverse events from other manufacturers via regular mail and/or a dedicated mailbox, forwarding them promptly for case processing.
  • Compliance with SDEAs: Ensure compliance with executed Pharmacovigilance Safety Data Exchange Agreements and perform routine reconciliations.
  • Finance Support: Assist the finance team in collating and processing invoices from safety and risk management program vendors.
  • Document Security: Maintain the security and integrity of Pharmacovigilance documents by filing them in a secure room or sending indexed files to offshore archival.
  • Project Prioritization: With minimal assistance, prioritize multiple projects, suggest solutions to complex issues, and deliver complete and accurate information within deadlines.
  • Audit/Inspection Readiness: Support North America and Global PV teams with audit/inspection readiness.
  • Compliance with Regulations: Perform all duties in accordance with Dr. Reddy’s business principles, corporate directives, SOPs, and government and industry guidelines.
  • Additional Tasks: Perform other relevant tasks as requested by management.

Candidate Profile

  • Educational Background: Bachelor’s degree in pharmacy.
  • Experience: 3-4 years of drug safety experience in the pharmaceutical industry with knowledge of global pharmacovigilance regulations.
  • Regulatory Knowledge: Working knowledge of ICH-GCP guidelines and global PV regulations, including FDA, Health Canada, and EU standards.
  • SOP Drafting Experience: Experience in drafting SOPs and Work Instructions and assisting in the preparation of training materials and quizzes to test SOP understanding.
  • Decision-Making Skills: Ability to make necessary decisions by applying FDA, HC, ICH-GCP, and GPVP standard regulations/guidance with minimal assistance.
  • Technical Skills: Proficient in MS Office (Word, Excel, and PowerPoint).
  • Communication Skills: Excellent communication skills needed to independently liaise with external PV vendors and internal teams (e.g., RA, QA) to obtain necessary information for daily PV activities.

Additional Information

  • Experience: 3-4 years
  • Qualification: Bachelor’s degree in pharmacy
  • Location: Hyderabad
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Pharmacovigilance
  • End Date: 30th July 2024
  • For more articles, Kindly Click here.For pharmaceutical jobs, follow us on LinkedIn

    For more jobs, kindly visit our job section.

    www.pharmaceuticalcarrier.com/Jobs

To apply for this job please visit careers.drreddys.com.