Data Quality Assurance Manager

2 days ago

Amrāvati, Maharashtra, India beBeePharmacovigilance Full time ₹ 8,00,000 - ₹ 12,00,000
Pharmacovigilance Specialist

Job Overview:

We are seeking a skilled Pharmacovigilance Specialist to join our dynamic team in Amravati, India. As a key member of the team, you will play a critical role in contributing to the activities performed in the Hub.

Responsibilities:

  • Perform local safety case receipt, processing, and data entry, quality control tracking, and ICSR follow-up for all safety information received from clients
  • Manage generic or client-specific email boxes as appropriate
  • Register, triage, assign, and coordinate the processing of vigilance cases
  • Follow up on requests with local reporters
  • Respond to queries from clients and reporters
  • Carry out periodic reconciliations to confirm proper handling of vigilance reports for clients
  • Support local pharmacovigilance activities as needed
  • Participate in audits and inspections, and resulting action plans

Requirements:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or science-related fields, or equivalent experience
  • Minimum 2 years' experience in pharmacovigilance, including data entry and QC of cases
  • Previous experience working under deadlines
  • Client communications
  • Knowledge of US and EU PV regulations
  • Pharmaceutical background, with strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment

Skills Required:

  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Excellent time management skills
  • Accountability and autonomy with assigned tasks
  • Process-oriented with good attention to detail
  • Effective communication skills, both written and verbal
  • Flexibility and adaptability to handle a dynamic workload
  • Works well under pressure and working to timelines
  • Safety database experience

What We Offer:

  • Opportunity to work with a dynamic team
  • Chance to develop your skills and knowledge
  • Competitive compensation package

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