Senior Manager, IPS Risk Management Operations

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Contributes to the risk management operational strategy for assigned products for International (non-US) BMS markets focusing on Additional Risk Minimization Measures (ARMMs). Acting as the subject matter expert and primary point of contact for Local Market Patient Safety teams the Senior Manager leads key workstreams to ensure global oversight standardization and clear communication of risk management requirements for effective local market implementation. This includes developing ARMMs tracking timelines measuring outcomes and providing operational metrics and key performance indicators to stakeholders as well integrating local market input into global risk management strategies.

Duties/Responsibilities:

Leads workstreams relating to the development maintenance and tracking of ARMM materials and other risk management measures as agreed upon by the Safety Evidence and Sciences/Safety Management Team Chair. This includes drafting educational content/artwork document management and coordinating work with vendors.
Gathers and integrates local market input into global risk management strategies.
Escalates ARMM safety variation requests as needed.
Provides operational metrics and ARMM key performance indicators to key stakeholders.
Tracks timelines and measures outcomes for ARMM implementation.
Supports and improves design and delivery of ARMM/RMP training programs.
Identifies and proposes process improvements for risk management systems.
Supports IT readiness and integration for risk management activities.
Ensures audit and regulatory inspection readiness.
Supports ad hoc risk management-related requests.

Reporting Relationship: Reports to Associate Director IPS Risk Management Operations

Qualifications / Experience

Demonstrated expertise in medical writing including authoring and editing educational and pharmacovigilance / regulatory documents (e.g. ARMMs RMPs patient/HCP materials).
Experience in quality assurance and regulatory compliance preferably relating to risk management activities.
Experience coordinating safety-related content development localization and finalization working with third party vendors and cross-functional teams.
Experience in developing training materials and operational communications for risk management activities.
Thorough understanding of risk management regulations and risk management processes.
Excellent interpersonal verbal and written communication skills (English Cambridge C2 equivalent) with proven experience of effectively engaging and influencing across different geographies and cultures.

More than 3 years experience in the Pharmaceutical Industry with a minimum of 2 years experience working in Pharmacovigilance preferably within risk management.

University degree (health or life science) or nursing qualification.

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The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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