YOUR TASKS AND RESPONSIBILITIES
• Leads and manages the Peru and Venezuela PV team and provides medical guidance in pharmacovigilance matters.
• Assists in the maintenance of company's compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety and assures the correct implementation and observation of all safety related Standard Operating Procedures (SOPs), Working Procedures (WPs) and Operational Instructions (OIs) of BHC PH referring to local safety activities.
• Assures the collection, review, processing and distribution of adverse event information on a country level regarding the Bayer products in all therapeutic areas; Guidessubmission of individual case safety reports to the local Health Authorities of Peru and Venezuela the according to the local regulations.
• Local safety issue and crisis management in collaboration with the Headquarter.
• Detection andescalation of local safety observations, review of local relevant medical literature according with the PV standard operations and procedures.
• Education and training within the local organization; documentation of topics addressed during the training and of participants in the training.
• Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the GPV standards and the protocol template.
• Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. market research, Active- Online-Listening) to ensure Pharmacovigilance principles are applied in the interaction with patients.
• Leads the local Safety Management Team (SMT) and liaise with the relevant expert functions in the local Safety RMP development and intervention implementation activities.
WHO YOU ARE
• Advanced scientific degree, Medical doctor
• A minimum of 3-5 years experience in a (global) healthcare organization, sp. Clinical Development and/or Medical Affairs and/or Pharmacovigilance
• Strong organizational and process management skills
• Strong financial reporting experience and skills and understanding of business systems
• Demonstrated project management capability
• Preferably in-depth experience in drug development process over different stages, esp. clinical development and clinical operations
• Fluency in English (written and verbal communication skills)