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Dr. Reddy’s Laboratories

3-4 years

N/A

Hyderabad

Bachelor’s degree in pharmacy

Verified Job

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Roles & Responsibilities:

  • Document Management: Draft procedural documents including Standard Operating Procedures, Work Instructions, and Guidance Documents to capture PV processes. Review, format, and route procedural documents authored by other team members.
  • Training Support: Assist in developing training materials and curricula for the global PV Team and affiliates. Develop and deliver adverse event reporting training for non-PV internal teams and drug safety vendors on a routine and annual basis.
  • Data Management: Perform and compile requests for information (RFI) with PV data, adverse event collection, case processing, signal and risk management, clinical studies, and PV safety concerns.
  • Regulatory Correspondence: Manage PADERS submission and publishing for all DRL products. Update PV shared drive with labeling updates and communicate with other PV stakeholders.
  • Strategic Information Provision: Ensure provision of strategic information and complete PV Due Diligence for potential product acquisitions/divestitures and create/modify Safety Data Exchange Agreements.
  • Compliance: Ensure compliance with executed Pharmacovigilance Safety Data Exchange Agreements (SDEA) and routine reconciliations. Support finance team in processing invoices from safety and risk management program vendors.
  • Audit Readiness: Support North America and Global PV team with audits/inspection readiness. Maintain document security and integrity.
  • Additional Duties: Perform other relevant tasks as requested by management. Prioritize multiple projects and deliver accurate information within deadlines.

Qualifications:

  • Bachelor’s degree in Pharmacy.
  • 3-4 years of drug safety experience in the pharmaceutical industry.
  • Knowledge of global pharmacovigilance regulations.
  • Proficient in MS Office: Word, Excel, & PowerPoint.
  • Working knowledge of ICH-GCP guidelines and global PV regulations (FDA, Health Canada, EU).
  • Experience in drafting SOPs and preparing training materials.
  • Ability to make decisions by applying FDA, HC, ICH-GCP, and GPVP standard regulations/guidance.

Skills & Attributes:

  • Technical skills in ICH-GCP and global PV regulations.
  • Experience in drafting SOPs and Work Instructions.
  • Proficiency in MS Office.
  • Ability to prioritize multiple projects and suggest solutions to complex issues.

For more details, please visit our career website.

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Dr. Reddy’s Lab Hiring for Pharmacovigilance Associate

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