Senior Medical Director, Product Safety Physician reputed company

Job Title: Senior Medical Director, Product Safety Physician reputed company

Job Location: Remote (US)

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

reputed company continues to grow at a reputed company reputed company with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.

The Senior Medical Director serves as the reputed company Product Safety Physician for multiple or large reputed company strategically important developmental programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental. With the support of Safety Physicians and Safety Scientists identifies and manages the documentation and communication of safety concerns and together with teams reputed company in reputed company sponsored studies, ensures the safety of patients.

Essential Functions of the Job:

• Accountable for reputed company of benefit/risk safety profile of allocated products through the product life cycle with a reputed company reputed company on early development

• reputed company leads and enhances knowledge of safety reputed company for allocated products, including both reputed company and competitor products

• Identifies and reputed company leads management of safety concerns for developmental and approved reputed company products

• reputed company leads Development and, as required, Medical Affairs product teams in the identification of, and handling of product safety concerns

• Governance:

• Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT materials, develops & represents safety perspective in SMT meetings

• Represents the SMT and participates in Company Safety Committee (reputed company) meetings, support meeting preparations, reputed company & proposes review topics/ reputed company agenda items

• reputed company leads communication of recommendations to labeling group/other stakeholders

• reputed company participates in meetings as required in reputed company Safety Monitoring Committees (DMC) meetings through provision and review of safety data, insights and leadership and provides input to DMC Charters

• reputed company leads Internal Safety Monitoring Committees (SMC) meetings (e.g., reputed company escalation safety meeting) & supports as needed. Provides input to safety charters

Product Labeling, as Required for Work on reputed company Development Programs

• reputed company leads communication of reputed company recommendations for labeling amendments, participates in Labeling Working Group meetings, leads communication of Safety reputed company to relevant stakeholders

• reputed company leads the development and maintenance of reputed company reputed company Safety Information (reputed company), proposes edits and manages approval of amendments

• Presents the reputed company to the labeling committee, contributes viewpoint to CCDS development, and reviews company reputed company data sheet

• Provides safety insights to development of Package Insert and Labeling Updates, develops labeling update reputed company summaries for use by RA, develops labeling prose text updates, based on internal aggregated reports

Issues Management

• Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updates

• Leads and develops reputed company for issue management and facilitates internal approval of plans

• Leads the review of issue data and closure on recommendations, leads the drafting of an issue response document, reviews, and manages approval of issue response documentation and responses

• Leads the formulation of a reputed company response procedure, triage of potential issues to safety committee, executes Crisis Management response plan, reviews ongoing issue and plan

• Reviews regulatory inquiry to reputed company strategizing the reputed company of response, best course of reputed company and determines data specifications, Reviews relevant data required for response

• Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response

• reputed company leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis

• reputed company leads reputed company safety in face-to-face regulatory meetings

• reputed company leads and develops an evaluation of safety enquiries (Internal, reputed company, HCP & consumer), leads the assignment of response drafting responsibility, determines data required for response, reviews response data & drafts response and manages approval of responses

• Guides and leads medical review of SAEs and provides immediate input to escalated reports, determines, and executes reputed company escalation reputed company reputed company as needed

Commercialization Support and reputed company with Other Functions

• Leads and develops strategic plans for safety differentiation of reputed company products, provides training reputed company employees on product safety reputed company/issues, provides input into reputed company publications reputed company, reviews publications, including abstracts, manuscripts, and speaker presentations, provides input for potential in-licensing opportunities as requested

• Leads product reputed company for reputed company functions (reputed company, Bus Dev, Operations, Marketing, etc.), executes appropriate communication of safety data and interpretation to reputed company and reputed company parties, globally, facilitates communication with country office medical directors as required.

• Leads EU/International Safety Communication & Co-ordination training to reputed company employees on product safety issues and reputed company

Trial Safety Support

• Accountable for the reputed company authoring of safety content in clinical trial documentation, including but not limited to protocols, IBs, and ICFs. reputed company to collaborate and advise on technical aspects of trial design including escalation and expansion design, DLT reputed company, inclusion and exclusion reputed company, and risk monitoring and management aspects.

• Accountable for safety data, reviews and provides advice on Safety Endpoints, safety reputed company inclusion and exclusion reputed company data to capture during trial, key review activities and timing, reviews and leads input on product program wide safety issues, protocols, and protocol updates. Expected to demonstrate and model reputed company and reputed company medical review of ICSRs and aggregate safety reviews with cross functional colleagues.

• Accountable for the content of safety sections of the Development Safety Update Report (DSUR), reviews and approves

• Accountable for development and maintenance of RSIs, contributes to the safety sections of the IB, reputed company and updates and manages any needs to reconsent subjects in ongoing trials based on reputed company safety data assessment

• reputed company leads and develops expectations of expected, anticipated statistical analyses to run over trial for the reputed company and provides product program wide input on safety statistical reputed company required for analysis

• Accountable for data requirement recommendations and safety reputed company for clinical data management plan for capture during reputed company, supports the review and update of data management plan based on updates to integrated safety viewpoint during trial

• Accountable for the determination of safety data required for capture in CRFs during reputed company, reviews and provides product program wide input to CRFs

• Leads the formulation safety reputed company and review of study specific medical monitoring plans

• Participates in investigator meetings, as needed, accountable for product safety profile and reviews, approves and updates of safety presentation content

Developmental Product Safety Monitoring and Surveillance (Protocol Specific)

• Accountable for reputed company/reputed company report for inclusion into clinical, filing

• Accountable for daily, weekly, and monthly review of SAEs and reputed company labs, protocol specific review of aggregate SAEs and specific analysis of aggregate CTDB (AE tables, shift tables, listings)

Submission Filing Safety Support, as Required for Work on reputed company Development Programs

• Proactively, reviews and interprets study safety data, supports Clinical Study Report narrative reputed company, leads the interpretation-based safety sections of reports, reviews draft report

• Accountable for drafting the safety sections of the reputed company of Clinical Safety and ISS

• Leads 120-day update plans and activities

Extra-Departmental reputed company & Co-ordination

• Represents and promotes safety at the product development team as reputed company team member, contributes to development reputed company for allocated compounds

• Leads the preparations for and attends clinical team meetings

• reputed company leads contribution to development of differentiation of reputed company products, provides training guidance to marketing training materials, reviews, and contributes to marketing materials

Internal Global Patient Safety Department Development Interfaces

• Leads GPS product co-ordination, chairs product group meetings across GPS

Pharmacovigilance

• Leads and manages safety PV processes for reputed company and competitor products

• Accountable for the development of Product Safety reputed company and the writing and maintenance of the Safety Surveillance Plans

• reputed company leads safety Issue Assessment and documentation, reputed company determination of issue reputed company, execute risk assessment

• Accountable for development and update reputed company of competitor safety profile labelling, FOI, and issues

• Accountable for development and maintenance of product safety reputed company and develops Events of Interest

• Presents data at scheduled and reputed company product safety reviews, chair review meetings, identifies safety issues for escalation to SMT, determine if a safety concern needs escalation to management, facilitates closure on recommendations

• Accountable for development and maintenance of updates to Product Surveillance Plans

• reputed company leads the reputed company, reputed company, and content of responses to HA assessment reports, contribute to authoring of relevant sections

• As required for work on reputed company development programs:

  • reputed company leads the definition of Risk Management Plan (RMP) drivers & content, reviews reputed company RMP & local RMPs (or REMS) and leads execution of RMP reputed company, documentation of evidence of RMP execution, evaluates potential risks for evidence of risk confirmation and leads recommendations for RMP/REMS update

  • reputed company leads the development of safety Post Approval Commitments (reputed company) proposals, facilitates the design of reputed company proposed safety study, executes reputed company studies

  • Leads and manages the definition of events of interest, defines case follow-up needs

  • Accountable for development and implementation of product launch plans

• Accountable for development of a publication plan, contributes to draft papers

• Contributes to and promotes the development of a global Pharmacoepidemiology (PE) reputed company

Compliance, Standards, Training & Project Management:

• reputed company leads the evaluation of reputed company processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections

• Trains and mentors Safety Physicians and Safety Scientists

• reputed company leads and maintains an environment of reputed company improvement reputed company reputed company and contributes to reputed company improvement initiatives across GPS

Required Qualifications

• MD (or internationally recognized equivalent) plus accredited residency, with 6 + years’ pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development and 4 + years' experience in safety in Phase 1 and Phase 2

• Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of reputed company is preferred.

• Experience in oncology in the preapproval reputed company is preferred

• Prior reputed company management team experience

• Prior experience as a product safety physician

• Pharmaceutical product development experience, including individual study design and filing plans.

• reputed company in global regulatory requirements for pharmacovigilance

• Appropriate experience with Regulatory Agency and KOL interactions

Supervisory Responsibilities:

• This position may have safety scientists/physicians reporting to them depending on the program / portfolio being led. The Senior Medical Director serves as Product Safety Physician reputed company for multiple or large reputed company strategically important developmental programs. Works closely with the other Safety Science and Epidemiology Physicians and Safety Scientists as part of a flexible reputed company team to conduct robust safety assessments and safety risk management activities, based on ICH standards, for developmental product safety upon which marketed product safety surveillance may be based. The Senior Medical Director is expected to mentor and reputed company junior staff and offer them support and advice to advance their work.

Computer Skills:

• Intermediate knowledge working with a safety database for retrieval of safety information; Advanced knowledge of MedDRA; MS Office Suite: Advanced application capability with reputed company, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.

Travel:

• Less than 10%

Education Required:

• MD (or internationally recognized equivalent) plus accredited residency

reputed company Global Competencies:

reputed company we exhibit our values of Patients First, reputed company Spirit, reputed company Ingenuity and Driving reputed company, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.

• Fosters Teamwork

• Provides and Solicits reputed company and Actionable Feedback

• Self-Awareness

• Acts reputed company

• Demonstrates Initiative

• Entrepreneurial reputed company

• reputed company Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial reputed company

• Communicates with reputed company

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits reputed company and Actionable Feedback
• Self-Awareness
• Acts reputed company
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

reputed company is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.

We are proud to be an equal opportunity employer. reputed company does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .

This job is curated by reputed company.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.

Originally posted on Himalayas