Vaccine Pharmacovigilance Benefit-Risk Scientist

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Job Description

OBJECTIVES/PURPOSE:

Responsible for providing support to Takeda’s Vaccine Pharmacovigilance Department in the monitoring of the safety profile of assigned products within agreed timeframes and to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and global and local regulatory requirements.

• Support developmental programs, including both early and late-stage development as required.

• Responsible for pharmacovigilance (PV) and clinical safety assessments for designated global/regional product(s).

• Support Vaccine Safety lead (VSL) for signal and PV life-cycle management activities for the assigned product(s)

ACCOUNTABILITIES:

• Perform pharmacovigilance and clinical safety activities as outlined by Takeda quality management system documents (e.g. applicable Procedures, Job Aids) including:

• Review of pharmacovigilance and clinical safety data and support VSL for safety signal management through literature research, safety data mining/analyses, and presentation of safety relevant data from any sources

• Review and/or approval of protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities

• Prepare or review Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations)

• Interact with external experts and regulatory agencies and partner/co-development companies

• Analysis of safety data and support in dose escalation/continuation of vaccination decisions

• Contribute to Safety Monitoring Plans and Risk Management Plans

• Prepare or review regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

• Direct the set-up of safety procedures and development of safety exchange agreements for co-development projects

• Perform activities required to serve as VBU PV representative as outlined in applicable Takeda quality management system documents (e.g. Procedures, Job Aids) including:

• Support the development and maintenance of the Reference Safety Information (RSI) for assigned products (e.g., Company Core Safety Information DCSI / CCSI, the respective information of the Core Data Sheet and Investigator's Brochure)

• Support the preparation of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS): Assists in the development and maintenance of RMPs and REMS, including the coordination with other line functions for associated activities such as updates, ongoing tracking of commitments and effectiveness measures, and provides analytical input for known and potential risks defined in RMPs and REMS. Ensure integration of Benefit Risk Management framework / tools / expertise in global development and commercialization process

• Reviews and performs clinical evaluation of individual case safety reports of Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) occurring in association with assigned products, including input for medical coding of events according to standard MedDRA terminology, as well as data cleaning

• Reviews clinical protocols and other clinical development documents to ensure adequacy of safety sections, assists in the preparation of other safety documents, as required (e.g., the Investigator's Brochure (IB), CCSI)

• Prepares and reviews Aggregate Reports (PSURs, US Periodic/Annual Reports, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).

• Performs signal detection analyses and evaluation of potential signals, incl. respective literature search

• Prepares, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators

• Provides input into responses to inquiries from internal sources, health care professionals, and other external sources

• Provides support as required for licensing activities, regulatory authority inspections, company audits, and for project product recall activities.

• Performs pharmacovigilance training and mentoring of internal and cross-functional team members

• Participates as a PV expert in Clinical Trial Teams, Clinical Development Teams, Data Monitoring Committee (DMC) meetings, Investigator meetings, as applicable

CORE ELEMENTS RELATED TO THIS ROLE:  

• Signal detection and management

• Safety information in clinical documents (Protocols, Investigator Brochures, SAPs, clinical study reports)

• Aggregate reports and ad-hoc safety reports

• Interactions with Regulatory Agencies

• Safety monitoring plans and risk management plans

• Product regulatory submissions and approvals

• Safety data exchange agreements

• Reference safety information and core data sheets

• Medical event coding

• Safety inquiries

• Pharmacovigilance expert

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education: Advanced life science degree (e.g. MSc or internationally recognized equivalent)

Skills:

• Minimum of 5 years’ experience in pharmacovigilance, clinical research or clinical development, including a minimum of 3 years in a global pharmacovigilance organisation. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required and ideally experience in filing vaccines marketing authorization applications.

• Vaccines and/or biotechnology industry experience preferred

• Strong investigational event and aggregate assessment/review/documentation skills.

• Extensive working knowledge of US/EU/APAC regulations and ICH guidelines.

• Proven experience in communicating with the FDA, EMA, and other global health authorities.

• Sound working knowledge of MedDRA coding.

• Excellent understanding of pharmacovigilance-related information systems.

• Expert in Aggregate Report preparation and review.

Desired Characteristics:

• Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.

• High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach".

• Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired.

• Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.

• Demonstrated success in building effective matrix working teams, systems, and processes; proven ability to identify, select and manage a variety of external resources.

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