Compliance Specialist

6 days ago

Aurangabad, Maharashtra, India beBeePharmacovigilance Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

Job Overview:

We are seeking a skilled professional to manage and maintain our Pharmacovigilance system.

The ideal candidate will have in-depth knowledge of national/regional regulatory legislation and guidelines, as well as experience in pharmacovigilance regulations of all countries.

Key Responsibilities:
  • Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system
  • Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance.
  • Ensure PV business continuity and after hours availability.
  • Lead and coordinate internal and external PV audits and inspections.
  • Monitor PV system performance and compliance of partners and distributors.
Required Skills and Qualifications:
  • In depth knowledge of national/regional regulatory legislation and guidelines.
  • Knowledge of the pharmacovigilance regulations of all the countries.
  • Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.
  • Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
  • Capable of troubleshooting and managing multiple projects simultaneously.
Benefits:
  • Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance.
  • Degree / Advanced degree in medicine or in life sciences or equivalent experience
  • Excellent communication skills including proficiency in verbal and written English

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