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Título: PV PQS Officer (CH) – São Paulo/SP
Cidade/Estado: Sao Paulo / São Paulo
AT Bayer, we work hard to make this company a better place for our employees – and the world a better place for everyone. “Health for all, hunger for none.” That’s our vision at Bayer.Bayer is a global company with core competencies in the areas of life sciences, health care and agriculture. As an innovation company, we set trends in research-intensive areas. Bayer’s products and services are designed to benefit people and improve their life quality. We are committed to diversity in all aspects for all employees and candidates, regardless of ethnicity, color, race, religion, origin, age, gender, gender identity or expression, sexual orientation, or other conditions. And all opportunities are open to people with disabilities. POSITION: PV PQS Officer (CH) – São Paulo/SP GET TO KNOW THE AREA: The Pharmacovigilance Product Quality Safety (PV PQS) Officer Consumer Health (CH) supports the PV PQS management group and especially PV Gatekeeper CH in coordinating, managing and overseeing all safety aspects of PQS matters (including critical product quality issue management, product technical complaints and adverse event [PTC + AE] management and product supply [PS] interface management) and issues for Bayer CH products on the market and in clinical trials (if applicable). She/he actively drives continuous improvements, cross-functional and cross-divisional alignments. The incumbent is a strong problem solver and communicator with a solid understanding of global regulations and standards to ensure implementation of PV processes including analysis/trends/safety data sets related to quality-safety topics as an expert.YOUR MISSION WILL BE TO:Supports PV PQS Gatekeeper CH as representative in Product Quality Safety Committees (PQSCs) as well as independent representation in non-complex PQSCs and handling of critical product issues which do not require escalation to PQSCs (under supervision of PV Gatekeeper). This may include drafting of health risk assessments, collection and preparation of materials and safety data to develop a safety position, cross-functional information.Supports PV PQS Gatekeeper CH in audits and inspections with regards to preparation, conduction and post-activities and report compilation for QPPV.Responsible for timely case processing and provision of scientific quality-safety evaluation of drug product, medical device and combination product for CH portfolio related PTC+AE reports in respective databases as per defined PTC+AE process. This includes interaction and clarification with other headquarter and country functions PV internally and externally. – Examples: PV Case Processing (Triage, Case Processors, Case Evaluators), Global Safety Leaders (GSLs), Medical Device Safety group, Pharmacovigilance Country Heads (PVCHs), and the local and global quality units (Country Quality Heads (CQHs), manufacturing sites/Responsible Quality Units (RQUs), and divisional Product Supply Quality Assurance).Cooperates with PV internal and external partners on PTC, PTC+AE and usability issue handling and related questions, technical-/ complaint error types and potential causal relationship to adverse events. Retrieves and reviews PTC/PTC+AEs, lack of drug effect (LODE), and usability issues and performs safety related evaluations in collaboration with GSLs and RQUs for complaint reviews, customer feedback, periodic safety update reports (PSURs)/periodic benefit risk evaluation reports (PBRERs), safety risk management plans (RMPs) as needed, as well as for audits and inspections on request.Gives input to Standard Operating Procedures (SOPs) and PV PQS internal procedures.Supports, and provides training in PV regarding handling of complaints/PTCs and product specifics, e.g. error types and associated safety risks.Support PV internal and external projects (e.g. New Product Developments [NPDs]), process optimization/efficiency gains, compliance relevant projects, business continuity) with impact on PQS and/or PQS management.ARE YOU READY FOR THE POSITION?Degree in pharmacy, medical or life sciences, or equivalent with experience in Pharmaceutical Production, Quality Control, and/or Quality Management/Quality Assurance or PharmacovigilanceGood basic medical, pharmacological, and statistical knowledgeGood knowledge of Global PV and complaint databases preferrableKnowledge of cGMP/cGLP, regulatory, Pharmacovigilance requirements and drug development process.Very good skills in project managementEnglish fluent in written and spokenExperience in global collaboration settingLocation: São Paulo/SPWhat´s in it for you?At Bayer we have established our benefits in three essential pillars, which integrate and converge to promote the life quality and well-being of our employees.Health Care PlanDental PlanMedicines SubsidyGymPass“Conte Comigo” – Psychological, chemical dependence, legal and financial assistance “Bem Nascer” – Health monitoring during pregnancy, no coparticipation in the health care plan, workshop for pregnant women (employees or partner of employees), extended maternity and paternity leave, daycare assistance, Bepantol baby, etc.Private Pension Plan Life InsuranceCoopBayer – Cooperative that aims at the financial education and giving credit for employeesHolidays bridge and holidays regular schedule, occurs all year round, including eve of National Holidays Vacations flexibility (within the provisions of the Brazilian legislation)**Bayer Country Club – Country Club facilities: Leisure area, game room, swimming pool, gym, party room and football pitch)*Working from Home policy *Flex Time and Short Friday*There may be some difference in the benefits package according to position and location**It depends on employee associationBayer continues to hire for all positions, the interviews and the onboarding process are being conducted virtually due to COVID-19. We have taken all the safety measures to take care of our employees and we are going through this together.
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