Data Management Specialist

4 days ago

Kanpur, Uttar Pradesh, India beBeePharmacovigilance Full time ₹ 12,00,000 - ₹ 15,00,000

Job Description:

  • We are seeking a skilled Data Management Specialist to join our team. This role will involve performing local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for clients.
  • The successful candidate will be responsible for managing generic or client specific email boxes as appropriate.
  • They will also register, triage, assign and coordinate the processing of vigilance cases.
  • In addition, they will follow-up requests with local reporters and respond to queries from clients and reporters.
  • This role requires the ability to carry out periodic reconciliations to confirm the proper handling of all vigilance reports for clients.
  • The ideal candidate will support and contribute to local pharmacovigilance (PV) activities performed by the Local Safety/PV department as needed.

Required Skills and Qualifications:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
  • 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases
  • Previous experience working to deadlines.
  • Client communications
  • Knowledge of US and EU PV regulations
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment

Benefits:

  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Excellent time management skills
  • Accountability and autonomy with assigned tasks
  • Process orientated with good attention to detail
  • Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
  • Flexibility and adaptability to handle a dynamic workload
  • Works well under pressure and working to timelines
  • Safety database experience

Others:

  • A deep understanding of pharmacovigilance principles is essential for this role.
  • The ideal candidate will have excellent communication and organizational skills.
  • This is a challenging yet rewarding role that requires strong analytical and problem-solving skills.
  • The successful candidate will be able to work effectively in a team environment and communicate complex ideas clearly.
  • This role offers a great opportunity for professional growth and development.

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