Safety Risk Lead - SSRM Job in Chennai at Pfizer

Pfizer is hiring for the role of Safety Risk Lead - SSRM!

Responsibilities of the Candidates

• Act as a point of contact for Safety in the Asset Teams, ensuring unified communication on safety matters and representing WWS position(s) on safety
• Represent 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 the Manager
• Evaluate safety data of any source with oversight, identifies and analyze safety signals, and present medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
• Provide disease area-specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her
• Assist with the 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
• Prepare and contributes to written safety assessments and benefit-risk evaluations
• Review and approve, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer’s products
• Ensure consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities
• Identify opportunities for consistency and standards for safety surveillance and risk management processes
• Innovate, champion, and implement 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
• Engage in inspection readiness support including provision of data to project managers for metrics and activity tracking
• Develop a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.
• Make decisions based on clinical experience
• Assess the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.

Requirements:

• MD (physician)
• Minimum Years of  Experience: 2 years
• 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
• Ability to influence internal and external stakeholders 
• Ability to act independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives
• Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills
• 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
• Strong scientific and medical knowledge, including fluency in the medical literature
• 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
• Effective verbal and written communication skills in English