(Senior) Director Pharmacovigilance (m/w/d)

Ort: Frankfurt am Main, Hessen, Deutschland
Gehalt: n.A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
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Our client is a global pharma company with over 45.000 employees in 28 countries. The company develops and markets innovative medicines for patients in the field of oncology and cardiovascular medicinal treatment.

(Senior) Director Pharmacovigilance (m/w/d)

Tasks:

  • Engage with global product teams to manage safety profiles
  • Provide strategic guidance for preparation of safety relevant parts of submission documents for marketed CV products as requested by European authorities
  • Management of Periodic Safety Update Reports (PSURs) , Risk Management Plans (RMPs) and Signal Detection Reports
  • Support EU Lead for PV evaluation for CV products and creation of response documents for health authority requests
  • Medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
  • Performs pharmacovigilance activities as function of European Headquarters including Medicinal Case Assessment for marketed and investigational drugs
  • Ensures compliance with all legal requirements with respect to Pharmacovigilance in Germany, initiates and controls continuous adaptation to new legal requirements
  • Supports global pharmacovigilance activities such as global working groups

Qualifications:

  • Education as Medical Doctor
  • 8+ years of experience in a similar position within the pharmaceutical industry
  • Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
  • Very good knowledge of international, European and German PV laws
  • Experience in people management (preferred)
  • Very good communication skills when dealing with interdisciplinary multicultural teams; Management experience is an advantage
  • Very good knowledge of English language (oral and written)

Benefits:

  • working in the office in Frankfurt or Munich
  • possibility to work partially from home
  • pleasant working atmosphere in a committed team
  • flat hierarchies and short decision-making paths
  • various internal and external catering options
  • options for childcare in the surrounding area
  • Accessibility: On-site parking and very good public transport connections

Mission:

Do you want to provide medical leadership at Clinical Safety & Pharmacovigilance for cardiovascular and/or oncology products by setting-up and leading a team of safety physicians? Are you interested in a challenging, global position in a company that combines history and innovation? Would you like to significantly improve health in the world? Are you an expert in the area of pharmacovigilance and are you ready for the next career step?

Your Point of Contact:

Ms. Margot Huber

m.huber(at)progressive.de

0 (+49) 176 / 557 39 180

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