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Associate Director - Global Safety

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Major duties and responsibilities are:

Internal & External Safety Expert

• Provide PV and risk management expertise to internal and external customers

• Safety expert for product

• Maintain knowledge of product, product environment, and recent literature

• Maintain 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

Impact

• 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.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1033304

Associate Director - Global Safety

Thane, Maharashtra
Full Time

Published on 02/01/2020