Ad- Medical Safety Adviser (Aggregate Report & Signal Detection)

Kelly Services India Pvt. Ltd.
  • Thane
  • 15-25 lakh
  • 0-5 years
  • Views
  • 22 May 2019

  • Others

  • Pharmaceuticals/ Life Sciences/ Clinical Research
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
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.


Job Posted By

Sairam
HR recruiter

About Organisation

Kelly Services India Pvt. Ltd.