Pfizer
Location
Chennai | India
Job description
He/she will provide organizational leadership within SSRM 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
Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.
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, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer s products
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
Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.
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.
Professional Experience Educational Requirements
MD (physician)
Minimum Years of Experience: 2 years
Additional Qualifications
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
Technical 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.
Job tags
Salary
