Director Safety Physician (m/f/x)
|Job Title:||Director Safety Physician (m/f/x)|
|Contact Name:||Marlene Inderhees|
|Job Published:||November 23, 2020 11:49|
Director Safety Physician (m/f/x) | Munich | Pharma
Do you want to provide medical leadership at Clinical Safety & Pharmacovigilance (CSPV) for cardiovascular products by setting-up and leading a team of safety physicians and scientists from the cardiovascular division and medical reviewers? 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?
What will your tasks as Director Safety Physician be?
- Cardiovascular Medical Co-leads DSE CSPV cardiovascular product team to manage safety profiles
- Engage with global CV 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, e.g. GWT Medical as needed
What does the position offer you?
- Type of contract: unlimited + full time
- Vacation: 30 days / year
- Working hours: 40 hours / week
- Salary: Basic salary + Bonus + company car
- Benefits: Opportunities for further qualification, a 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, wide range of health and sports activities (e.g. company doctor); highly flexible working model; attractive remuneration and benefits offer
- Accessibility: On-site parking and very good public transport connections
- Start date: As soon as possible
- Education as Medical Doctor
- 8+ years of experience in a similar position within the pharmaceutical industry
- Experience in people management (preferred)
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Very good knowledge of international, European and German PV laws
- Very good communication skills when dealing with interdisciplinary multicultural teams; Management experience is an advantage
- Very good knowledge of English language (oral and written)
Information about our client:
The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thromotic diseases and in the field of oncology. Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!
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