PhV Scientist, Established Prod & Signal Mgm - Medical Safety Unit Team, Romania
Date: Feb 18, 2021
Location: Bucharest, RO, 050713
Company: Teva Pharmaceuticals
Company Info
PhV Scientist, Established Prod & Signal Mgm - Medical Safety Unit Team, Romania
Teva Pharmacovigilance (Patient Safety) unit is hiring a PhV Scientist, Established Prod&Signal Mgm to join the Medical Scientific Unit located in Bucharest, Romania
The main responsibilities of PhV Scientist, Established Prod&Signal Mgm consist in:
• Provide medical assessment for ICSRs associated with Teva marketed products
• Contribute safety related input to documents related to Teva products
• Participate in processing of post marketing cases
• Case processing of CT cases, reconciliation and additional related tasks
• Take part in databases search strategy discussions and be responsible for the data retrieval for safety assessment and evaluation
• Take part in providing medical safety information and assessment associated with marketed products to external and internal Teva stakeholders, mainly but not limited to:
- Clinical implications and health hazard associated with quality issues concerning generic products
- Health authority queries related to generic products
• Perform signal management activities related to Teva products
• Take part in preparing & providing training to newcomers or other MSU members in different topics as required.
• Take part in writing SAE Management Plan and review of the safety reporting section in study protocols
• Take part in QC of various documents/reports
• Take part in writing safety update periodic reports
The ideal candidate should have:
• Bachelor Degree in Pharmacy, Biology, Veterinary Medicine or in nursing/ Paramedical studies degree
• Very good understanding of medical concepts and a confident user of English medical terminology
• Experience in pharmacovigilance is an advantage Good communication skills, analytical capability, writing
• Assertiveness, ability to work under pressure, sometimes with tight deadlines
• Strong written and verbal English communication skills
• Flexibility to adapt to shifting team priorities
• Advanced knowledge of Microsoft Office platforms
• Ability to work collaboratively and effectively in a global team environment
• Knowledge of PhV regulations (e.g., FDA, EMA, etc) is an advantage
• Details oriented
We offer:
• An exciting and challenging job in an innovative, flexible and growing company
• A team of young, hard-working, open-minded and friendly colleagues
• Initiation and trainings in Pharmacovigilance field
Function
Sub Function
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