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
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