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Local Person Pharmacovigilance-India

Cencora Pharmalex
Freshers years
3-6 LPA
10 Feb. 2, 2024
Job Description
Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

Your Job

  • Local Person for Pharmacovigilance (LPPV) in India acting as National Contact Person for Pharmacovigilance in INDIA acc. to applicable local regulation.
  • The Local Person for Pharmacovigilance in India is responsible for the establishment and maintenance of the marketing authorization holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations.
  • Close cooperation with the global PV system of the client as well as related global and local departments and functions
  • Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
  • Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
  • Deputy is assuming responsibility in case of planned or unplanned absence
  • Decisions regarding handling of safety-relevant issues in close cooperation with the client and global PV Regional Manager
  • Full-fledged LQPPV, with experience in post-marketing and clinical trials. Relevant experience in:
  • Local Literature Screening
  • Local Risk Management Plan
  • Additional Risk Minimization Measures
  • Market Research and Patient Support Programs
  • PV intelligence
  • Signal detection
  • PV awareness training
  • Inspections and audits
  • Gap assessment
  • Digital and social media monitoring
  • PVAs
  • Other relevant aggregate reports
  • ICSR management

 

Your Profile

  • Autonomous, concentrated and high-quality work
  • Ability to work in a team
  • Sense of responsibility
  • Hindi (native speaker)
  • Proficient command of English
  • University degree in Medicine, Pharmacy or Life Science
  • Several years’ experience and profound knowledge in the field of pharmacovigilance
  • Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
  • Detailed knowledge of related SOPs (global and local)
  • Participation in all relevant courses of instruction such as internal trainings and applicable external courses
  • Experience in all operative tasks that are performed by the members of the pharmacovigilance department
  • Familiarity with industry principles of pharmacovigilance
  • Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Ability to analyze and solve problems and to develop possible solutions

 

We offer

  • A collaborative and diverse work environment that values innovation and inclusivity.
  • Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team
  • Ability to work independently and collaborate effectively in a global, cross-cultural environment.
  • Flexible working hours striking a good work life balance
  • Business interaction with nearly all branches of the company across 5 continents
  • A broad range of initiatives for personal development and professional training