Pharmacovigilance Associate, backup Affiliate Safety Representative / Amsterdam


De opdrachtgever

Farmaceutisch bedrijf in Amsterdam.

De omschrijving

  • Implementation of PSRM standards and procedures, as applicable.
  • Tracking and communicating changes in local PV regulations that may have an impact on standards and procedures of Global PSRM
  • Development and implementation of local procedures, as necessary.
  • Pharmacovigilance training for local personnel/agents responsible for pharmacovigilance activities.
  • Local implementation and tracking of activities in accordance with Risk Management Plan (RMPs).
  • Collection of PV-relevant information and reporting of Individual Case Safety Reports (ICSRs).
  • Reconciliation of relevant documents (such as ICSRs) exchanged with Global PSRM, affiliate non-PV functions, commercial partners, service providers, etc.
  • Local literature screening as required by local legislation or guidance.
  • Timely identification and appropriate response to incidences of noncompliance.
  • Report (PSUR) in liaison with local regulatory affairs.
  • Provide safety information required for preparation of periodic safety report, upon request.
  • Informing Regional Leads concerning urgent safety restrictions.
  • Notify Regional Lead, Lead Quality Management, PSRM, EEA QPPV, Global Head PSRM of any announced local PV audit by a 3rd party or authority inspection.

De eisen

  • Medical, pharmacy or life-sciences MSc. degree
  • Minimum of 2 years experience in the pharmaceutical industry with professional experience in Pharmacovigilance.
  • Language: Dutch, English

De arbeidsvoorwaarden

Uitstekende arbeidsvoorwaarden.
Fulltime functie (40 uur/wk).

Contactinformatie

Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Maliebaan 80
3581 CW Utrecht
tel 030 231 7350
mobiel 06 50650550

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