דרושים Quality Analyst - Fixed Term Contract ב-טבע ב-Romania, Bucharest

As Lead GPV Professional, you will support Pharmacovigilance Data Quality and Case Processing Metrics, ensuring accuracy, compliance, and inspection readiness across global PV operations. Reporting to the ICSR Quality & Metrics Team Lead, you will drive oversight, analysis, and continuous improvement of ICSR processes while collaborating cross-functionally to enhance data integrity and operational excellence.

• Ensure compliance with global PV regulations and internal policies, owning key SOPs, WIs, and JAs.
• Strengthen ICSR Quality & Metrics by maintaining data integrity, inspection readiness, and seamless submissions.
• Transform data into insights by analyzing reports (e.g., QlikSense, V-Safe) and driving meaningful improvements.
• Collaborate with cross-functional teams to enhance compliance reporting and streamline processes.
• Lead projects that improve case quality, compliance, and performance.
• Act as a business owner for selected GPV tools, shaping the SDI strategy.
• Promote continuous improvement through root-cause analysis and innovative solutions.
• Share knowledge, mentor others, and help the team reach its annual goals and KPIs.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 3 years of Biopharmaceutical/CRO industry experience, including a large international organization.
• At least 1 year of direct people/project leadership experience.
• Experience in handling Health Authority Inspections.
• Project Management experience is an advantage.
• Fluent 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.

• Overall responsibilities for activities of engineering.
• Monitoring / review of procedures, cGMP records in engineering store and to ensure compliance.
• Prepare / review of Engineering store SOP’s in Glorya Electronic Data Management System.
• To ensure readiness of the department for regulatory inspections and ensure their compliance.
• Up keeping of engineering store compliance.
• Initiation / execution of Change Controls, Deviations, Investigations, CAPA’s in Trackwise System for engineering store and its timely closure.
• Follow up for any deficiency and corrective actions.
• Physical stock verification and it’s reconciliation to confirm the availability of stock for effective procurement of material in co-ordination with cross functional departments and share the list of materials availability monthly once to immediate supervisors.
• Upgradation / maintenance / alteration / renovation of engineering store facility in coordination with engineering department.
• Monitoring of receipt / issuance of miscellaneous, UD clearance of materials/miscellaneous, consumables and ancillary materials and its documentation.
• Ensure verification of physical inventory count as per inventory count cycle.
• To motivate the team member for reporting of near miss events and non-safety incidents.
• Monitoring of disposal of scrap from scrap yard area and up keeping of scrap yard.
• Monitoring of disposal of miscellaneous/chemical process as per standard procedure in engineering store with its documentation and controls.
• Printing/pasting of quarantine labels on ancillary materials.
• Ensure compliance of material handling in engineering store as per SOX.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Handling of SAP R/3 System (engineering store related transactions), Trackwise System and Glorya Electronic Data Management System (as applicable).
• Ensure all assigned training requirements are completed in learning platform (Studium).
• Co-ordination with cross-functional departments for smooth functioning of department activities.
• Ensure departmental safety by giving the awareness training for handling of miscellaneous, consumables and ancillary materials to the engineering store persons and implementation of good safety practices in engineering store.
• To follow the normal safety precautions in working area and ensure departmental safety at all times.
• Responsible for maintaining disciplined work culture in working area.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Any other responsibilities assigned by the reporting authority.

• Education /Qualification: Diploma / Degree in Engineering
• Experience: 7- 9 years of relevant experience

• Lead the management and continuous optimization of the global website, ensuring content is relevant and engaging for our consumers.
• Become a key pillar in digital communication projects including social ecosystem development, social listening and performance tracking.
• Assist in shaping the global communication campaigns.
• Collaborate with local market teams to adapt and implement global strategies.
• Contribute to brand planning and execution activities through gathering consumer insights
• Brand performance analysis.

• Currently enrolled in a Bachelor's or Master's program in Marketing or Sales.
• Proactive mindset – ready to learn and collaborate with drive and passion.
• S trong communicator – able to collaborate effectively across diverse teams and communicate clearly, whether it’s with local markets or digital agencies.
• Digital savvy – comfortable navigating the digital space.
• Ownership mentality – taking initiative and accountability.
• Detail-oriented – attentive to execution without losing sight of timelines.
• T eam player – enthusiastic about engaging with people from around the world, in an open manner.

Associate Director Brand Management

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.

•
• 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.

• Acting as the Responsible Person (RP), ensuring full compliance with GDP, national and EU pharmaceutical regulations, and narcotic distribution laws.
• Independently overseeing market release, recalls, and complaints related to medicinal products.
• Leading quality management processes, including audits, SOPs, CAPAs, change control, and documentation systems.
• Communicating directly with national health authorities and hosting inspections with full readiness at all times.
• Maintaining licenses and authorizations related to medicinal and narcotic products, including reporting to authorities.
• Providing strategic quality guidance and partnering closely with the General Manager and cross-functional commercial teams.
• Leading and executing risk management activities across the distribution chain.
• Participating in European-level quality councils and ensuring implementation of regional initiatives locally.
• Ensuring continuous GDP training, quality awareness, and inspection readiness.
• Being the key local quality contact for both internal stakeholders and external regulatory bodies.

• Master’s Degree in Pharmacy, Medicine, or Biology (Pharmacist license mandatory); advanced degrees are a plus.
• Minimum 3 years of experience in a RP, QP, or QA Manager role in a pharmaceutical company, ideally in a large international organization.
• Proven ability to work independently, with full ownership of RP and QA responsibilities.
• Strong understanding of GDP, GMP, and Romanian/EU legislation including those related to narcotic substances.
• Experience managing health authority inspections, quality systems, and regulatory submissions.
• Excellent communication skills and ability to influence at all levels of the organization.
• Track record of implementing quality systems, continuous improvement, and issue escalation.
• Fluent in English; Romanian language proficiency is essential for regulatory communications.
• Strong problem-solving, decision-making, and risk assessment capabilities.

• Competitive compensation package aligned with experience.
• Benefits package: meal vouchers, healthcare subscription to a private clinic.
• Highly professional team and organizational culture with strong values.
• Professional development within the company.

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.