Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : GMPE Manager
Job Description
Role Summary
The Global Medical Product Evaluation (GMPE) Manager is an integral member of the multifunctional Medical Affairs team and reports directly to the GMPE Team Lead. The GMPE Manager provides medical leadership and global product strategy for all products in the assigned portfolio and supports product maintenance and product defense activities.
Role Responsibilities
• Provides strategic medical oversight and leadership on overall (planned and ad-hoc) product maintenance and defense activities for the respective products.
• Provides medical leadership and subject matter expertise on product maintenance activities that includes potential impact of amendments in product labeling on the overall benefit /risk of the product, medical input for clinical overviews and clinical efficacy section in support of Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Periodic Safety-Update Reports (PSURs), Addendum Reports (ARs), product renewals etc.
• Partner with PGS, Communications and Medical Information on queries, press releases and letters involving supply interruption or out of stock situations.
• Provides strategic medical input to Product Withdrawals and discontinuations in collaboration with regional country medical, Chief Medical Affairs Office (CMAO) and Chief Medical Office (CMO).
• Provides medical leadership and subject matter expertise on Pfizer global supply (PGS) issues by being a key member of Area Quality Review Teams (AQRTs) and authorship of Health Hazard Assessment (HHA) reports through a centralized process across the BUs that determine market action of impacted products.
• Lead Product Benefit Risk Committees (PBRCs) and present assessment of clinical efficacy at PBRCs, BU-Benefit-Risk Committees (BU-BRCs) and E-BRCs.
• Provide subject matter expertise and strategic leadership on reformulation efforts, abbreviated and supplemental submissions (aNDAs, sNDAs, MMAs, aMMAs) and Rapid Response Teams (RRTs) to assure appropriate support for deliverables globally.
• Provides medical input on regulatory, safety, legal, PCO and other internal product enquiries.
• Provide subject matter expertise for product PLR conversions, Risk Management Plans (RMP), Risk Evaluation & Mitigation Strategies (REMS,), Label harmonization, and external and internal audits.
Candidate Profile
• PhD, PharmD, MPharm, 6+ years’ experience in a global pharmaceutical environment.
• Must be able to manage a large portfolio of products.
• Has the functional and technical knowledge and skill to do the job at a high level of accomplishment and function independently.
• Is proficient in Microsoft word, PowerPoint and excel, as well as has “user” knowledge of Pfizerclinicaltrials.com, GDMS, PEARL, and other corporate document systems.
• Must be proactive, pragmatic, flexible person with strategic thinking, communication & presentation skills.
• Excellent communication and presentation skills
• Strong interpersonal skills
• Teamwork and solution driven approach.
• Key focus on Compliance and Governance.
• Proven track record of high performance and producing outstanding results.
• Change Management-Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; can comfortably handle risk and uncertainty.
• Time management- Uses his/her time effectively and efficiently; concentrates his/her efforts on the more important priorities.
• Process Management- builds efficiencies and new processes; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; can simplify complex processes; gets more out of fewer resources.
• Organizational Agility- understands the origin and reasoning behind key policies, practices, and procedures; understands the cultures of organizations.
• Work experience in the functional area viz. Global Medical Product Evaluation is preferred.
• Ability to collaborate with internal and external stakeholders in a professional manner and must work well on multiple tasks and effectively prioritize to meet personal and team goals in a matrixed team environment.
• Able to manage a large portfolio of products.
• Must be able to work independently without direct supervision.
• Knowledgeable about respective functional areas, knows how to get things done both through formal channels and the informal network.
Required Skill Set
Has the functional and technical knowledge and skill to do the job at a high level of accomplishment and function independently. Is proficient in Microsoft word, PowerPoint and excel, as well as has “user” knowledge of Pfizerclinicaltrials.com, GDMS, PEARL, and other corporate document systems. This position requires a proactive, pragmatic, flexible person with strategic thinking, communication & presentation skills. He/she will contribute to ongoing efforts to enhance team effectiveness through involvement in continuous improvement initiatives. The individual must be able to work independently without direct supervision and function effectively. The individual must be able to manage a large portfolio of products. Product Maintenance and Defense related activities and outputs is required.
Additional Information
Experience : 6+ years
Qualification : PhD, PharmD, MPharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th January 2025
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