Location: Bangalore, India
Type: Full-time
Experience Level: Mid-level (Minimum 2 years of experience)

About the Role:

We are looking for a dedicated and detail-oriented Pharmacovigilance Specialist to join our client’s team in Bangalore. The successful candidate will play a critical role in ensuring the safety of pharmaceutical products by monitoring, assessing, and reporting adverse drug reactions (ADRs). This role is essential for maintaining regulatory compliance and safeguarding patient health.

Key Responsibilities:

• Adverse Event Reporting: Collect, monitor, and evaluate adverse drug reactions (ADRs) and ensure timely and accurate reporting to regulatory authorities and other stakeholders.
• Data Management: Maintain and update pharmacovigilance databases with relevant safety data, ensuring accuracy and completeness.
• Case Processing: Perform initial triage, data entry, and narrative writing for individual case safety reports (ICSRs). Assess the seriousness and expectedness of adverse events.
• Signal Detection: Participate in signal detection activities to identify potential safety risks and trends. Conduct preliminary assessments and escalate findings as necessary.
• Regulatory Compliance: Ensure all pharmacovigilance activities comply with relevant regulations, guidelines, and standard operating procedures (SOPs), including ICH-GCP, FDA, and EMA requirements.
• Risk Management: Support the development and implementation of risk management plans (RMPs) and risk mitigation strategies for marketed and investigational products.
• Safety Communication: Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and clinical development, to communicate safety information and updates.
• Training and Development: Stay updated on current regulations, guidelines, and industry best practices. Participate in training sessions and contribute to the continuous improvement of pharmacovigilance processes.
• Documentation: Prepare and review periodic safety update reports (PSURs), summary bridging reports, and other pharmacovigilance-related documents.

Required Qualifications:

• Educational Background: Bachelor’s degree in Pharmacy, Life Sciences, or a related field. A Master’s degree or additional certifications in pharmacovigilance or drug safety are preferred.
• Experience: Minimum of 2 years of experience in pharmacovigilance or drug safety, ideally within the pharmaceutical industry.
• Technical Skills:
  • Proficiency in pharmacovigilance databases and software.
  • Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH-GCP, FDA, EMA).
  • Experience in adverse event reporting, case processing, and safety data analysis.
• Soft Skills:
  • Excellent analytical and problem-solving abilities.
  • Strong written and verbal communication skills.
  • Detail-oriented with a high level of accuracy in work.
  • Ability to work independently as well as part of a team.

Preferred Qualifications:

• Industry Experience: Prior experience in handling pharmacovigilance activities in a global pharmaceutical company.
• Certifications: Certification in pharmacovigilance or related fields is an advantage.

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional growth and development within a global pharmaceutical company.
• A collaborative and supportive work environment.