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Περιοχή

Εταιρία:
ICAP PEOPLE SOLUTIONS
Ημερομηνία Δημοσίευσης:
15-09-22
Τύπος απασχόλησης:
Πλήρης
Κωδικός θέσης εργασίας:
6275/PVM/ESS/GR
Κατηγορία εργασίας:
Υγεία
Περιοχή εργασίας:
Νομός Θεσσαλονίκης

Safety Risk Lead

ICAP Executive Search & Selection is one of the premium consultancies and part of ICAP People & Employment Solutions,
the largest HR Services Provider in Greece and Cyprus. With more than 50 years of experience,
we specialize in assessing and recruiting Senior to Middle Level Executives across all sectors.

ICAP Executive Search, on behalf of Pfizer, the Leading Global Biopharmaceutical Company,
is looking for high caliber professional for the position of the Safety Risk Lead.

Safety Risk Lead

(Ref. code 6275/PVM/ESS/GR)

Role Summary:

The Safety Risk Lead (Senior Manager) is accountable for the global medical safety management of Pfizer products and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients.

He/she will provide organizational leadership within the Safety Surveillance & Risk Management and within Pfizer, including:

  • Performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
  • Works with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice

Role Responsibilities:

  • Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety Chairs RMCs and Core Working Groups for his/her assigned products with oversight
  • Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions) as agreed with Manager
  • Evaluates safety data of any source with oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
  • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her
  • Assists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
  • Prepares and contributes to written safety assessments and benefit-risk evaluations, reviews and approves safety documents
  • Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities
  • Identifies opportunities for consistency and standards for safety surveillance and risk management processes
  • Innovates, champions and implements novel approaches to safety surveillance and risk management across Pfizer’s portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
  • Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking
  • Makes decisions based on clinical experience
  • Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities
  • Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required

Candidate Profile:

  • MD degree or another related field
  • At least 2 years of experience to include Medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/or Scientific, and/or Pharmacovigilance, and/or Drug development
  • Disease area-specific knowledge preferred
  • Awareness of safety risk management internal and external environment, including applicable regulations and guidances
  • Knowledge of drug development process and post-marketing experience, including an understanding of safety context across the drug lifecycle
  • Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments
  • Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management
  • Understanding of the scientific basis for therapies and drug-induced diseases
  • Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight
  • Ability to integrate data to support benefit/risk decision-making
  • Understanding of statistics and analytical tools
  • Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development
  • Strong scientific and medical knowledge, including fluency in the medical literature
  • Effective verbal and written communication skills in English
  • Ability to influence internal and external stakeholders
  • Ability to act independently, seeking guidance as appropriate; recognize other colleagues’ areas of expertise and engage them effectively to achieve team objectives
  • Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills

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