דרושים Pharmacovigilance Scientist ב-טבע ב-Romania, Bucharest

• Prepare and review written procedures including SOPs, and protocol test procedures for laboratory analysis.
• Maintain a clean and safe work enviroment, including work area, instrumentation and testing materials.
• Ensure sample and data traceability throughout all testing processes.
• Accurately perform calculations and statistical analyses, ensuring they reflect the raw data.
• Ensure test controls and monitors are accurately recorded and reviewed.
• Continually work to optimize the results of the instruments with new parameters or instrument setups.
• Evaluate and implement new analytical approaches, including software tools, to further strengthen the group’s technological capabilities.

Quality responsibilities

• Adhere to cGMP and GLP regulations.
• Follow all company policies and procedures.
• Ensure compliance with current regulations and complete required training on time.
• Properly record, interpret, and manage analytical data.
• Review data quality and recommend improvements to methods or procedures as needed.
• Review test results and peer work for accuracy and compliance.

Project Management

• Meet project deadlines.
• Collaborate with other departments to improve workflow and ensure successful project completion.
• Problem-solving and troubleshooting skills.
• Demonstrated planning and organizational skills in order to complete R&D activities.
• Design, implement, and manage studies related to drug product characterization.

• Work independently and as part of a team to meet organization and projects objectives.
• Demonstrate adaptability, flexibility, and forward-thinking in technical matters.
• Engage in continuous learning, review scientific literature, and attend meetings to stay current with new developments.
• Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages, such as Empower, Chromeleon or similar software, with the ability to learn new applications as needed.
• Exceptional oral and written communication skills to all levels of the organization.

M.S. / B.S. degree in Chemistry, Biochemistry, Pharmacy or related scientific field (Chemistry strongly preferred) with 0 - 4 years of experience in the pharmaceutical industry.
Ph.D. in analytical chemistry, biochemistry, or related field with 1-2 years experience.
Strong analytical knowledge across multiple techniques, including at least HPLC, UV, GC, particle size analysis, Karl Fischer titration, and TLC.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

As anyou will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout the product lifecycle and provide comprehensive safety information to patients, prescribers, and regulators.

• Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products and non-assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety review/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
• Review complex Health Hazard Assessments and Health Authority requests.
• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
• 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 as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
• Represent PV in cross-functional Product Label Working Group. Conduct evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.
• Provide PV support and safety contributions to Health Authority submissions and responses. Represent safety during due diligence of products.
• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality, etc.) and external stakeholers (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products. Collaborate with other cross-functional teams to ensure execution of the safety strategy.

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• Clinical practice experience and/or epidemiological degree/training
• Experience working in pharmacovigilance and drug safety, as a safety physician –
• Proven ability to handle safety surveillance tasks and chair safety committee meetings
• Ability to serve as a subject matter expert
• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority
• Ability to work cross-functionally within a matrix / international team across multiple time-zones
• Oral and written
fluency in English

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.