PV Professional

6 days ago

Bengaluru, Karnataka, India beBeePharmacovigilance Full time ₹ 5,00,000 - ₹ 8,00,000
PV Specialist Role

We are seeking a skilled PV Specialist to join our team. As a key member, you will play a pivotal role in ensuring the high-quality execution of pharmacovigilance processes.

Key Responsibilities:
  • Literature Review: Design and implement comprehensive search strategies using databases such as Embase, Medline, PubMed, and Ovid to ensure timely and accurate safety data collection.
  • Regulatory Impact Assessment: Assess regulatory changes and contribute to process simplification to maintain compliance.
  • Pharmacovigilance Support: Collaborate with teams on case processing, training, quality assurance, audits, and inspections to guarantee seamless operations.
  • Consulting & Knowledge Management: Serve as a consultant or Single Point of Contact (SPOC) for case-related activities and maintain a repository of process updates and regulatory changes.
  • Effective Communication: Maintain open communication with internal departments and external stakeholders to ensure transparency and cooperation.
  • Data Analysis & Quality: Analyze quality data for trends and prepare the team for process stabilization while ensuring regulatory compliance by meeting key performance indicators.
  • Independent Initiatives: Operate independently and make valuable decisions in response to dynamic regulatory requirements.
  • Training & Mentoring: Conduct workshops, training sessions, and other interactive activities to educate the team on process improvements and error trends. Mentor new hires in case processing and evaluate their progress.
Required Skills and Qualifications:
  • Educational Background: Bachelor's or higher degree in life sciences, pharmaceutical, or healthcare fields.
  • Experience: Minimum of 3-4 years in pharmacovigilance with a focus on literature review processes in Individual Case Safety Reports (ICSR).
  • Expertise: Solid knowledge of pharmacovigilance concepts, regulations, and procedures, along with advanced proficiency in Microsoft Office.
  • Skills: Excellent communication, interpersonal, analytical, and problem-solving skills. Ability to adapt to shifting team priorities.
Benefits:

This is an excellent opportunity for individuals passionate about delivering high-quality results in a fast-paced environment. If you have a strong background in pharmacovigilance and excellent communication skills, we encourage you to apply.

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