Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post: Manager - ASRL
Job Description:
• ASRLs perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
• ASRLs may act as a Point of Contact for Safety in the Product Teams, ensuring a unified communication on safety matters and representing WSR position(s) on safety.
• Our goal is to develop the ASRL to become a Safety Risk Lead (SRL, director level or above) if their capabilities and performance enable this career progression to occur.
Responsibilities
Performs proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection, risk assessment and safety risk minimization.
Colleague capability will drive nature and complexity of assigned responsibilities and activities:
• ASRL in SSRM may be assigned as the product safety management team (e.g. Risk Management Committee) Chairs and Product Team safety representatives. They will collaborate closely with the relevant WWS Safety Strategy Business Unit Group Head to support the appropriate BU safety strategies.
- The ASRL obtains guidance from the relevant WWS Safety Strategy Business Unit Group Head to meet the BU Safety Strategy goals.
- ASRLs may be assigned to act as a Safety Point of Contact to the Asset Product Teams, ensuring a unified communication on safety matters for WSR/WWS.
• Providing and accumulating product-specific pharmacovigilance expertise and applying this to various products assigned to the ASRL.
• Performing frequent proactive holistic safety review for products across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available from WWS/WSR and elsewhere (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data).
• Ensuring consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSR/Safety Evaluation and Reporting authors.
• Performing ad hoc special scholarly safety surveillance and risk management activities rapidly to meet specific needs in the BUs, such as Rapid Response Team deliverables/emerging safety issue white papers/product Due Diligence Assessments.
• Identifying opportunities for consistency and standards for safety surveillance and risk management approaches and processes within a product family and across business units.
• Innovating, championing and implementing novel approaches to safety surveillance and risk management across business units: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
• Engagement in inspection readiness and support. Provision of data for metrics and activity tracking. The ASRL may support product teams locally or globally. May be assigned to chair/lead/support various Safety Management Teams (e.g. RMC/SRT/POD etc.), on one or more products or group of products, for one or more Business Units.
Qualifications
EDUCATION AND EXPERIENCE:
• MD (physician) or DVM (veterinarian) preferred. Others: PhD; PharmD (pharmacist); MSc; or equivalents. Appropriate Pharma experience in SS & RM.
Find more info on Next Page...
Subscribe to Pharmatutor Job Alerts by Email
• 4-5 years of relevant experience
• Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
• Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process preferred.
• Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle preferred.
• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-today activities and collaborative skills.
• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
• Ability to work effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
• Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues' diverse opinions and bringing group to consensus. Next steps and actions are clear.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• See also Technical Skill Requirements section.
TECHNICAL SKILLS:
• Safety data review, safety data assessment, clinical safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums.
• Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities.
• Strong Matrix partnering, inclusiveness and collaborative working relationship with Safety and Regulatory colleagues, including engaging Safety Strategy Group Head, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engages WSR & WWS colleagues in RMCs and Product teams as needed.
• Effectively communicating resource, timeline and other issues that have e.g. regulatory impact, to the Safety Strategy Group Head(s).
• Working effectively when co-located with AND when remote from product teams/leaders/managers.
• Championing high quality SSRM deliverables and innovation.
Additional Information:
Experience: 4-5 Years
Qualification: MD, DVM, PhD, PharmD, MSc.
Location: Chennai-Tamil Nadu
Functional Area: R&D
Employment Type: Full Time
Job Type: Salaried
Req ID: 15202BR
See All B.Pharm Alerts B.Sc Alerts Bangalore Alerts
See All Other Jobs in our Database
.png)
