Teva Pharmacovigilance Scientist 

Romania, Bucharest 

866377979

As a Pharmacovigilance Scientist you will support the safety profile of the assigned medicinal product throughout the product lifecycle (in collaboration with a Safety Physician, when applicable)

• Review and evaluate safety information associated with Teva products and provide medical and scientific input for (including but not limited to) Health Authority requests, signal evaluation documents and health hazard assessments.
• Support the management of patient safety throughout different lifecycle stages of assigned Teva products, including retrieving and analyzing data to assist the review and evaluation of safety information (in collaboration with a Safety Physician, when applicable).
• Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures (ARRMs) as well as management of these plans throughout the product’s lifecycle. Contribute to measuring effectiveness of ARRMs.
• Participate in Product Safety Group (PSG) and coordinate all PSG related activities; support major safety issues escalations to senior safety governance committees as well as other forums attended by Teva’s senior management.
• Perform signal management activities related to Teva products.
• Retrieve data for assessment of clinical implications and health hazards associated with quality issues related to Teva products.
• Write or review HHAs and write responses to HA requests.
• Take part in preparing and providing training to newcomers or other members in different topics as required.
• Take part in and/or lead internal and/or cross-functional working groups, projects, and/or forums.
• Review portions of, and contribute to, the writing of periodic reports (PSUR, PADER, AR) involving assigned products.
• Consults and works with other functional teams both within and outside of PV to help define strategies and plans for important milestones and activities in assigned products.
• Represent the function and provide support during audits and inspections.
• Support the Safety Physician during due diligence of products.

• Bachelor’s degree in pharmacy, biology, veterinary medicine, nursing, paramedical studies degree or Pharm D.
• Preferably, minimum 2 years of experience in patient safety/pharmacovigilance: solid knowledge in pharmacovigilance concepts, regulations and procedures.
• Solid medical or pharmacological knowledge.
• Advanced knowledge of Microsoft Office platforms.
• Flexible to adapt to shifting team priorities.
• Fluent in English, spoken and written.

• Interpersonal and People Skills: Ability to interact with individuals at a variety of functional levels with both internal and external personnel and to perform cross-functionally.
• Communication Skills, both written and oral: Communication style should be diplomatic and direct, but not confrontational. He or she must be able to deliver and summarize information in a logical, articulate and clear manner. Ability to communicate with both internal and external stakeholders.
• Planning & Organization Skills: Ability to plan, schedule, and prioritize the work according to the goals of the organization. Is able to break down work into the process steps in order to achieve the required outputs.
• Proactive Behavior: Ability to try to solve a problem before it has occurred. Acting in advance rather than reacting or waiting for instructions.
• Professionalism Skills: Strives to gain as much knowledge and expertise as possible, and is capable of working efficiently under pressure. Holds himself/herself and others to the highest professional and ethical standards.
• Results and Performance-Driven: Assumes personal ownership and accountability for all Teva products under his/her responsibility; consistently delivers results that meet or exceed expectations.
• Problem-solving Skills: Creativity and practical experience to solve problems that arise in the workplace.

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