Regulatory Affairs Specialist

2 days ago

Ahmedabad, Gujarat, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 28,00,000
Job Title: Regulatory Affairs Specialist - PharmacovigilanceAbout the Role

This is an exciting opportunity to join our team as a Regulatory Affairs Specialist - Pharmacovigilance, where you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions to relevant authorities.

Key Responsibilities
  • PSUR and ACO Scheduling: Schedule and submit PSURs and ACOs in a timely manner to ensure compliance with regulatory deadlines.
  • PADER/PSUR/PBRER Coordination: Coordinate the preparation and submission of PADER/PSUR/PBRER documents as per their applicable dates.
  • Request Handling: Handle requests received from central and local regulatory affairs and PV departments within specified timelines.
  • Safety Review: Conduct thorough safety reviews to identify potential risks and ensure compliance with regulatory guidelines.
  • Risk Benefit Analysis: Conduct risk benefit analysis to ensure that benefits outweigh risks and comply with regulatory requirements.
  • RMP Related Activities: Participate in RMP-related activities, including coordination with global teams and internal stakeholders.
  • Signal Management: Manage signals detected during pharmacovigilance activities and coordinate follow-up actions as necessary.
  • EURD Database Maintenance: Maintain EURD database and coordinate with global teams to ensure data accuracy and compliance.
  • XEVMPD Database Maintenance: Ensure the maintenance of XEVMPD database and coordinate with global teams for data accuracy and compliance.
Requirements
  • Bachelor's Degree: Bachelor's degree in life sciences, pharmaceutical sciences, or a related field.
  • Experience: Minimum 2 years of experience in regulatory affairs or a related field.
  • Skills: Strong knowledge of regulatory requirements, excellent communication skills, and ability to work in a team environment.
Benefits

We offer a competitive salary package, comprehensive health insurance, and opportunities for professional growth and development.

Contact Information

Please contact us at [your email address] or [your phone number] for more information about this role.

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