Director Patient Safety (PR-33474118) Bayern, Deutschland

Our client, an international pharma company specialised on developing and delivering a broad range of lifesaving therapies in the field of oncology and cardiovascular medicine, is seeking highly qualified candidates for their headquarter in Bavaria to fill the position

 
Director Patient Safety (m/f/x)
 

Responsibilities:

• Leads a team of safety physicians
• Engages with global product teams to manage safety profiles
• Provides strategic guidance for preparation of safety relevant parts of submission documents for marketed products as requested by European authorities
• Management of Periodic Safety Update Reports (PSURs) , Risk Management Plans (RMPs) and Signal Detection Reports
• Supports EU Lead for PV evaluation 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

Profile:

• Medical Doctor with working experience in Pharmacovigilance (at least 5 years) across all key processes in an international environment
• Expertise in the fields of Cardiovascular Medicine and/or Oncology preferred
• Fluent business English (oral and written)
• Experience managing people preferred

 

Benefits:

• an interesting, diversified and challenging position
• good contractual conditions
• Home office and flexible working models
• social benefits of a modern company
• professional environment where you will have the opportunity for personal growth

 
Your point of contact for this position is Ms. Margot Huber
mehr...

zur Vakanz

Weitere Jobs von Aplitrak