Pharmacovigilance Manager
Istanbul, Turkey, 34000
Who we are
The opportunity
Pharmacovigilance Manager will be responsible to monitor and evaluate the safety information of our products, ensuring compliance with global pharmacovigilance regulations and internal policies.
How you’ll spend your day
- Monitor and evaluate the safety information of our products, ensuring compliance with global pharmacovigilance regulations and internal policies.
- Handle submission and documentation of safety reports, including PSURs, CCSI, RMPs, and other regulatory documents.
- Collaborate with cross-functional teams to facilitate timely and accurate reporting of adverse events to regulatory authorities.
- Develop, implement, and maintain processes and standard operating procedures to ensure adherence to pharmacovigilance guidelines and regulations.
- Provide guidance and support to internal teams on safety requirements, pharmacovigilance processes, and best practices.
- Serve as a point of contact for external partners, including regulatory agencies, regarding drug safety issues and concerns.
- Participate in the development and maintenance of risk management plans and safety-related documents for our products.
- Communicate relevant safety information to healthcare professionals, patients, and regulatory authorities as necessary.
- Stay up-to-date with changes in pharmacovigilance regulations, guidelines, and industry trends, and implement any necessary updates to processes.
- Participate in audits and inspections related to drug safety activities, ensuring compliance with all applicable standards.
- Train and mentor new members of the drug safety team, providing support and sharing expertise as needed.
- Engage in cross-functional projects and initiatives aimed at improving and optimizing drug safety processes.
- Maintain accurate and complete documentation of all drug safety activities in compliance with regulatory and company standards.
Your experience and qualifications
- Bachelor's degree in life sciences, pharmacy, or a related field.
- 2+ years of experience in drug safety, pharmacovigilance, or a related area within the pharmaceutical industry.
- Strong understanding of local pharmacovigilance regulations and guidelines.
- Experience in safety data review, adverse event analysis.
- Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external partners.
- Strong analytical skills, attention to detail, and the ability to interpret and communicate complex safety data.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with safety databases or pharmacovigilance systems.
Already Working @TEVA?
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