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Hiring For Global Safety Officer @ Anri Solutions

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 Hiring For Global Safety Officer

Job Description

Job Description

  • Provide PV and risk management expertise to internal and external customers
  • Safety expert for product
  • Maintain knowledge of product, product environment, and recent literature
  • Mhaintain PV expertise, and understanding of international safety regulations and guidelines
  • Lead cross functional Safety Management Teams (SMTs) and some Global Pharmacovigilance internal team(s)
  • Communicate with and represent PV position within project/product teams, with external partners,
  • Key opinion leaders, and Health Authorities, and during internal and external negotiations
  • Provide strategic and proactive safety input into development plans
  • Support due diligence activities and pharmacovigilance agreements

    • Impact

  • Ongoing assessment of the safety status of the product
  • Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, Statistical Analysis Plans, Program Safety Analysis Plans, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
  • Review, preparation, and/or contribution to questions from health authorities, ethics committees,
  • Internal Review Boards (IRBs), external partners
  • Management of product safety alerts, as needed
  • Ensuring the Global Pharmacovigilance (GPV) position is well articulated to and understood by its
  • internal and external customers
  • Establishment of credibility of GSO function and of GPV

    • Signal Detection and Assessment

  • Responsible for signal detection and analysis
  • Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
  • Identify and implement proactive safety analysis strategies to further define the safety profile for both marketed products and products in development
  • Lead aggregate safety data review activities and coordinate safety surveillance activities
  • Participate in safety governance process, including presentation of safety analyses

    • I mpact

  • Signal detection and analysis
  • Development of safety action plans and implementation, as appropriate
  • Enable effective development of product safety
  • Enable appropriate risk management
  • Enable up-to-date risk communication (e.g. labeling)

    • Risk Assessment/Risk Management/ Benefit-Risk Assessment

  • Provide proactive risk assessment
  • Co-lead benefit-risk assessment with other relevant functions
  • Participate in benefit-risk governance process, including presentation of benefit-risk analyses
  • Develop risk management strategies and plans and monitor effectiveness
  • Collaborate with Center of Excellence for Risk Management and Safety Epidemiology

    • Impact

  • Optimization of the product benefit risk profile
  • Development of REMS, Risk Management and Development Risk Management plans
  • Identification and implementation of risk mitigation or other corrective actions as necessary
  • Regulatory compliance
  • Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
  • Submission Activities:
  • Represent safety position in cross functional submission teams
  • Ensure generation, consistency, and quality of safety sections in submission documents
  • Write responses or contributions to health authorities' questions
  • Support preparation and conduct of Advisory Committee meetings

    • Impact

  • Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:
  • For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports
  • For marketed products: Response to health authority question/request for information, Core Safety
  • Information updates, periodic reports and over the counter (OTC) switches

    • Report Writing

  • Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation
  • Lead the preparation of Clinical Overview to support labelling changes
  • Lead the Safety part of the Company Core Safety Information (CCSI) creation and update
  • Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.

    • Impact

    • Regulatory Compliance.

    Skills and Education

  • For MD, Board certified/Board eligible or equivalent is preferred; For other degrees, advanced post graduate qualifications (Master or PhD) are preferred
  • For MD, Minimum of 3 years and for other degrees, minimum 5 years total experience in international PV or equivalent relevant industry experience with relevant clinical experience considered.

    • MBBS/MD Degree
    • Excellent clinical judgment
    • Capability to synthesize and critically analyze data from multiple sources
    • Ability to communicate complex clinical issues and analysis orally, including formal presentations,and in writing
    • Able to develop and document sound risk assessment
    • Demonstrates initiative and capacity to work under pressure
    • Demonstrates leadership within cross-functional team environment

    Required Candidate profile

    9+ Years (MBBS or MD with 3 Years Clinical + 6 Years International Pharmacovigilance (PV) Experience (With Aggregate Reporting / Signal Detection/ Risk Management )

    Job Classification

    Industry: Pharma, Biotech, Clinical Research
    Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
    Role Category: Medical Professional
    Role: Medical Professional
    Employement Type: Full time

    Education

    Under Graduation: MBBS
    Post Graduation: Medical-MS/MD in Any Specialization
    Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required

    Contact Details:

    Company: Anri Solutions Hr
    Location(s): Pune

    + View Contact

    Keyskills:   doctor drug safety physician drug safety specialist aggregate reporting mbbs medical officer signal processing pharmacovigilance physician drug safety associate

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    ₹ 25,00,000 - 32,50,000 P.A

    Anri Solutions

    ANRI Solutions HR Services Pvt. Ltd. is a Delhi based leading employment expert, offering a full range of options to help businesses and individuals choose their way in the contemporary world of work. We employ large number of people every day through a network of our employees providing effective s...

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