Pharmacovigilance Senior Officer
Αθήνα, GR
πριν από 6 μέρες
  • Pharmathen Pharmaceuticals is a privately owned, vertically integrated pharmaceutical company, focused on the development and marketing of pharmaceutical products in more than 85 countries ;
  • with more than 1100 employees in all continents, Pharmathen offers a world of opportunities!

    Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to recruit a Pharmacovigilance Senior Officer to join our Pharmacovigilance team at our Marousi, Athens premises.

    As a Pharmacovigilance Senior Officer , the ideal candidate will be responsible for day to day performance of PV tasks as per GVP & global safety requirements.

    More particularly : What you’ll do :

    What you’ll do :

  • Review day to day pharmacovigilance aspects including receipt, database entry and processing of adverse event reports (ICSRs, SUSARs)
  • Analyze ICSRs / SUSARs for completeness, consistency and pro-actively ensure adequate and timely follow-up
  • Review scientific / medical literature to identify reports on adverse events or other important safety information on assigned products
  • Write, manage submission and / or peer-review of aggregate reports for assigned products (i.e. Risk Management Plans, REMs, Periodic Safety Update Reports, Development Safety Update Reports, Addendums to Clinical Overviews, PADERs, Annual Safety Reports, Pharmacovigilance reports for combination products)
  • Run the Signal detection routine, evaluate the statistical results and construct reports proposing actions
  • Assist in reconciliation activities as per company’s standard procedures (SOPs)
  • Interact with clients, affiliates and other stakeholders that are related to the duties of the described position
  • Assist in pharmacovigilance audits and inspections
  • Mentor and train new pharmacovigilance (junior) officers as appropriate
  • Review and implement in the company’s Pharmacovigilance System changes in the EU, US and ROW Guidelines affecting the regulatory or quality management requirements for adverse drug reactions
  • Compile or update current pharmacovigilance standard operating procedures and other quality-controlled documentation applicable to PV system operations
  • Requirements

    The ideal candidate should have :

  • Bachelor’s degree; life sciences or equivalent
  • Msc degree in equivalent field will be considered an asset
  • Fluency in English
  • At least 2 years of pharmacovigilance experience within a pharmaceutical industry or services provider environment
  • Previous experience in adverse event processing, safety databases and literature screening
  • Eudravigilance & MedDRA coding certification will be considered assets
  • Job-Specific Skills :

  • Excellent communication skills both writing and speaking
  • High level of computer literacy
  • Highly flexible, adaptable and experienced in fast paced working environment
  • Ability to work on multiple projects and prioritize tasks, excellent time management and problem-solving skills
  • Ability to work accurately with close attention to detail
  • What you'll gain :

  • Involvement in a high-caliber, team-oriented and dynamic atmosphere
  • Exposure to challenging business issues and practices
  • Great opportunity to leverage and develop your business knowledge and skills
  • Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

    Submit your application no later than 17 / 09 / 2021

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