PhV Safety Physician (Temporary) - Medical Safety Unit Team, Romania
Teva Pharmacovigilance (Patient Safety) unit is hiring a PhV Safety Physician to join the Medical Scientific Unit. In this unit we lead drug safety across the entire Teva portfolio and throughout the product lifecycle. In partnership with other Teva stakeholders, our MSU safety physicians continuously identify and define risks of our drugs and propose measures to manage or mitigate them. In this way, we maximize the benefit-risk ratio of Teva drugs and provide comprehensive safety information to patients, prescribers and regulators
The tasks as PhV Safety Physician mainly consist of:
• Continuous monitoring of the safety profile of Teva drugs, in order to identify and define risks and propose measures to manage or mitigate them.
• Appropriate assessment of benefit risk information;
• Medical evaluation of Individual Case Safety Reports (ICSR),
• Preparation of responses to regulatory inquiries on product safety issues and contribution to regulatory documents.
• Accountable for medical evaluation/interpretation of aggregate safety data of products assigned including signal detection and evaluation, regulatory safety reports (PSUR, PADER, AERS data), and ad hoc safety review/assessments.
• Participation of Global Pharmacovigilance activities; supporting PhV operations
• Participation in label review and revision;
• Support the Legal Department in safety related issues
The ideal candidate should have:
• MD degree. Epidemiology degree or training a plus.
• Board eligible/certified or equivalent residency. 1+ years clinical practice experience preferable.
• Very good command of English, proficient scientific writer.
• Good communication skills, analytical capability, writing;
• Assertiveness, ability to work under pressure in a stressful environment,
• Strong written and verbal 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
• 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