PhV Scientist, Established Prod & Signal Mgm - Medical Safety Unit Team, Romania

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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
 

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