Regulatory Affairs ofertas em United States

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

It’s impossible to list everything you’ll do here because every day is different. But a few things are clear:

• Implement and ensure compliance to the Baxter Pharmacovigilance (PV) system for medicinal products and biologics in assigned countries, in compliance with the local national regulations/standards; Global PV legislations/ standards; and Baxter policies/ procedures at a local, regional and global level
• Act as a local Qualified Person Responsible for Pharmacovigilance in assigned countries (as per applicable local legislation)
• Perform appropriate Safety Risk Management activities in assigned countries in order to assure oversight of medicinal product safety and to ensure that appropriate action be taken when necessary, e.g., implementation of risk management activities
• Maintain a thorough understanding of and comply with the Baxter Pharmacovigilance Quality System and Policies
• Ensure all safety information at a local level is captured in the Global Pharmacovigilance Safety database and submitted to regulatory authorities as per regulatory requirements, within reporting timelines
• Ensure appropriate liaison with country Medical Affairs, Regulatory Affairs, Clinical, Quality, Business Units, Legal, etc., to ensure Pharmacovigilance input into country strategic planning for products Throughout their lifecycle
• Continually and proactively improve and develop the PV system and department to meet the needs and requirements of Baxter, and Pharmacovigilance regulations and standards

Main Accountabilities:

Local QPPV Role

• In the capacity of Local QPPV (Local Qualified Person Responsible for Pharmacovigilance), have an oversight of all pharmacovigilance activities as per applicable local legislation

Safety Risk Management Activities

• Identify the local regulatory requirements for RMP (Risk Management Plan) submissions, communicate the requirements to the Global team and provide local inputs as required. Implementing risk minimization measures locally as appropriate
• Identify, escalate and communicate all relevant local critical safety issues/signals
• Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures
• Maintain an overview of the safety profiles of medicinal products, of any emerging safety concern or other information relating to evaluation of the benefit-risk of medicinal products for which Baxter holds a marketing authorization in assigned countries

PV Quality Systems

• Have a thorough understanding of and comply with the Baxter Pharmacovigilance Quality system and policies
• Maintain expert knowledge and awareness of local pharmacovigilance regulations and implement as appropriate
• Ensure adequate understanding of audit and inspection preparation and readiness
• Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities per identified roles
• Ensure compliance with procedure for document management retention and archiving
• Understand and implement the document change management process and act as SME (Subject Matter Expert) for local procedures
• Ensure all training requirements for the role are met
• Identify appropriate stakeholders and ensure they are trained on PV reporting requirements/procedures
• Build alignment and collaboration with local Regulatory Affairs, Medical Affairs, clinical Operations, Quality Assurance, and Business Unit teams
• Communicate effectively all relevant safety information and compliance concerns with the AP Regional PV
• Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan)
• With regards to third party agreements
• Perform due diligence and ensure the appropriate PV/safety requirements are incorporated into the agreements
• Perform regular review of the agreements to ensure safety requirements are aligned to the current regulatory requirements and perform reconciliation of data between the third party and Baxter
• Have responsibility for the oversight of Safety signals for agreements where the Third party is the MAH (Market Authorization Holder)

Baxter PV Signal Management

• At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician
• Collection of as much AE case information as possible
• Escalation of requests, received directly local PV contact or indirectly (by country RA/Country QA) from Regulatory Authorities relating to product safety, efficacy and quality

Case Intake

• Manage the receipt and capture process for adverse event (AE) and other safety information report collection in the Pharmacovigilance safety database
• Various sources of AE include but are not limited to; spontaneously reported cases from patients, HCP, nurses, Baxter employees (Including AEs associated with product complaints and AEs associated with medical queries). Social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers
• Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database
• Perform the initial assessment on the case validity, check for core case elements. Perform duplicate checks and request for case deletion as required
• Perform a seriousness assessment and assess expectedness against the local label
• Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database
• Determine the requirements for follow up information and manage the process for collection and handling queries from the Global team
• Re-assess the follow up information in the context of case validity, seriousness and expectedness; capture all follow up information and source documents in the Pharmacovigilance safety database
• Perform ongoing tracking and local quality check and AE cases for follow up and submission requirements
• Manage patient identified batch review requests as required
• Perform reconciliation activities for AE cases as required

Regulatory Submissions

• Maintain expert knowledge of the regulatory reporting requirements and ensure the reporting rules in the system are aligned to the local reporting requirements
• Manage the process for expedited submission of AEs to local authorities with translation of documents as required. Track submissions in the Pharmacovigilance safety database and archive all submission records
• Respond to submission related queries from the local regulatory authorities and archive all regulatory related correspondence

Other Responsibilities

• Provide the appropriate local inputs for the PSMF (Pharmacovigilance System Master File) sections
• Understand any specific local regulatory report requirements (e.g., AE line listing), request the required information from the Global team and submit the reports to authorities as per regulatory requirements
• Provide backup support to Local PV SEA cluster activities, as needed
• Ensure all obligations are met as per safety data exchange agreements (SDEA) with business partners
• Escalation of requests, received directly by local PV contact or indirectly (by Country RA /Country QA) from Regulatory Authorities relating to product safety, efficacy and quality must be disseminated to Pharmacovigilance Officer In charge, Director, Asia Pacific (APAC) Regional PV and other stakeholders as per Baxter procedural requirements
• Other tasks as assigned by Regional APAC Pharmacovigilance

Educational Background & Experience:

• Bachelor’s Degree, preferable to Bachelor’s Degree in Pharmacy, Nursing, or Medical Science or an equivalent degree in a scientific field
• At least 1 year experience in related pharmacovigilance role within the pharmaceutical industry

Qualifications & Competencies:

• Expert knowledge of the PV relevant local regulatory framework, and sound knowledge of international PV relevant regulations and standards, e.g., GVP
• Working knowledge of the clinical drug development process and GCP
• Excellent analytical & problem solving skills
• Excellent oral & written communication & interpersonal skills
• Operates effectively in a team environment
• Ability to work under strict deadline and changing priorities with some supervision
• Attention to detail
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity