Senior Manager – Risk Management Plan
Job Location
Mumbai (Mumbai Development Center – EPDC), India
Job Category
Medical and Clinical Affairs
Organization
Abbott
Employment Type
Full-Time
Experience Required
Minimum 8 years of pharmaceutical industry experience in Pharmacovigilance, including at least 5 years of experience in Risk Management Plan (RMP) preparation in accordance with EU GVP Module V requirements.
Educational Qualification
Master of Pharmacy, PhD, or equivalent Master’s degree in Health Sciences or a related discipline.
Job Overview
The Senior Manager – Risk Management Plan will provide strategic leadership, oversight, and operational support for the preparation, implementation, and maintenance of global Risk Management Plans (RMPs). This role ensures compliance with international regulatory requirements, pharmacovigilance standards, and risk management legislation while supporting patient safety and product lifecycle management.
The position requires expertise in global regulatory frameworks, safety data analysis, and cross-functional collaboration with medical, regulatory, and clinical teams to ensure effective risk management practices across global pharmaceutical products.
Primary Responsibilities
Serve as the central point of contact for Risk Management Plans across global product portfolios.
Monitor and evaluate global risk management legislation and regulatory guidelines, ensuring timely implementation into standard operating procedures and templates.
Lead the planning, preparation, and maintenance of Risk Management Plans in compliance with global standards.
Ensure adherence to regulatory requirements and maintain accountability for timely RMP submissions and updates.
Core Responsibilities
Provide strategic guidance and subject matter expertise to cross-functional teams including Medical Affairs, Regulatory Affairs, Clinical Development, and Product Safety.
Maintain strong knowledge of global pharmacovigilance regulations, clinical study requirements, and drug development frameworks.
Support risk categorization and characterization through scientific evaluation and cross-functional consultation.
Conduct gap analysis of regulatory frameworks, risk management guidelines, and standard operating procedures to ensure compliance.
Monitor evolving regulatory trends including biosimilar regulations and additional risk minimization measures.
Analyze pharmacovigilance safety data and develop scientifically robust reports and safety summaries.
Collaborate with Regulatory Affairs to align regulatory strategies with Risk Management Plan updates.
Ensure compliance with global regulatory formats including EU GVP Module V Rev 2 and other regional RMP requirements.
Manage risk management documentation and localization requirements for emerging markets and global regulatory submissions.
Coordinate responses to regulatory authority queries and deficiency letters within required timelines.
Support global affiliates in the preparation and maintenance of local Risk Management Plans.
Develop and deliver training programs and materials related to risk management planning.
Conduct pharmaceutical and medical assessments of drug safety data, including adverse reactions, drug interactions, toxicity, and medication errors.
Identify new safety signals and evaluate potential risks affecting product safety profiles.
Manage external vendors supporting medical writing activities, including Risk Management Plans and periodic safety reports.
Regulatory and Technical Expertise
Advanced knowledge of EU Good Pharmacovigilance Practices (GVP) Module V and global RMP requirements.
Understanding of regulatory frameworks across European Union, Latin America, and emerging markets.
Experience in additional risk minimization measures tracking and effectiveness evaluation.
Proficiency in electronic Common Technical Document (eCTD) formatting and submission processes.
Key Competencies
Strong analytical and scientific evaluation skills.
Advanced project management and regulatory compliance expertise.
Cross-functional collaboration and stakeholder management capabilities.
Effective negotiation, communication, and presentation skills.
Ability to operate independently within a global regulatory environment.
Expertise in Microsoft Office tools and regulatory documentation systems.
Role Scope and Accountability
Accountable for ensuring organizational risk management procedures comply with global and local regulatory requirements.
Operates with a high level of independence while collaborating with internal stakeholders and regulatory teams.
Responsible for maintaining patient safety standards through effective risk evaluation and regulatory compliance practices.
Career Opportunity
This role offers an opportunity to contribute to global pharmacovigilance strategy, regulatory compliance, and patient safety initiatives. The position provides exposure to international regulatory frameworks, strategic risk management processes, and cross-functional leadership within the pharmaceutical industry.
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