Assistant Manager - PV

Company Overview

Company details are not specified.

Job Summary

The Assistant Manager - Pharmacovigilance (PV) will support the Lead Named Safety Contact (NSC) in the collection of Human Safety Information (HSI) and Adverse Events (AEs) related to clinical trials. This role is crucial in ensuring the timely reporting of HSI/AEs to local regulators and maintaining compliance with local regulations and GSK global Pharmacovigilance requirements.

Responsibilities

• Assist in the collection and reporting of Human Safety Information (HSI) and Adverse Events (AEs) to the Global Service Provider.
• Review Safety Mailboxes regularly to manage regulatory reporting actions.
• Redact cases with insufficient consent and forward them to the Global Service Provider.
• Respond to queries from the Global Safety Provider and coordinate PV-related activities.
• Prepare India-specific Periodic Safety Update Reports (PSUR) for submission to relevant health authorities.
• Maintain trackers for PV-related activities and respond to health authority queries.

Qualifications

• Educational Background: Bachelor’s degree in Science, Pharmacy, Life Sciences, or a related field.
• Experience: Minimum of 3 years in pharmacovigilance operations.
• Technical Skills:
  • Strong understanding of pharmacovigilance regulations and methodologies.
  • Proficiency in safety databases and IT systems, including Excel.
  • Excellent attention to detail and organizational skills.
• Soft Skills:
  • Effective communication skills, both written and verbal.
  • Strong time management and prioritization abilities.

Preferred Skills

• Master’s degree in Health Sciences or a related field.
• Experience in clinical trial safety reporting and regulatory submissions.
• Familiarity with aggregate reports such as PSURs and risk management plans.
• Ability to work collaboratively in a matrixed environment.
• Experience with audits and inspections in a pharmacovigilance setting.
• Industry experience in pharmacovigilance is preferred.

Experience

• A minimum of 3 years of experience in pharmacovigilance operations is required.

Environment

Work setting, location, and environmental conditions are not specified.

Salary

Salary information is not specified.

Growth Opportunities

Potential career advancement opportunities within the company are not specified.

Benefits

Offered benefits such as insurance, paid leave, and work policies are not specified.