Associate Director, Safety Operations Portfolio

Purpose:

This position manages a team of Portfolio Leads and Product Leads who are responsible for Safety Operations-related scientific activities input and expertise across assets in all therapeutic areas. This position leads the SOPROL (Safety Operations Product Leadership) team. This role works with Therapeutic Area Heads and senior/executive scientific leaders across Global Patient Safety(GPS) Global Medical Affairs Clinical Development and Regulatory Affairs. The role is responsible for ensuring that accurate high-quality and timely Safety Operations scientific input and support are provided to PSTs across assets (development and on-market) from discovery to end of life. Safety Operations oversees the intake processing and reporting of patient safety information.

Responsibilities:

Develops communicates and implements the strategy for providing scientific expertise and support across all Safety Operations activities for assets in support of PST responsibilities and deliverables. This includes but not limited to regulatory responses submissions and launches audits/inspections clinical trial protocol reviews etc.

Responsible for oversight of the accuracy quality and timeliness of all scientific input for the end-to-end spectrum of Safety Operations activities for pharmaceutical and device assets (in development and on-market). Reviews scientific content through an enterprise and international lens. Provides direction to SOPROL team members to enhance quality of scientific input.

Interprets and implements global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities. Collaborates with the QPPV Office in the application of international regulatory requirements in Safety Operations activities.

Builds strong collaborative relationships with PST Therapeutic Area leadership and Group Medical Directors as well as senior leaders in Epidemiology and Medical Aesthetics & Device Safety Clinical Trial Safety & Insights. Provides Safety Operations scientific recommendations to help optimize safety strategies for high-profile assets.

Maintains a comprehensive understanding of the strategic direction of AbbVies pipeline and commercial priorities. Applies understanding in making recommendations on ICSR forecasting and broader Safety Operations business planning.

Proactively prepares GPS leadership communications to share crucial insights from ICSR data across key assets that further strengthen safety understanding narratives and actions.

Manges talent development and utilization of SOPROL Portfolio Leads and Product Managers. Engages inspires coaches and mentors team.

Partners with senior scientific leadership cross-functionally (Global Medical Affairs Regulatory Affairs Clinical Development etc.) to advance the priorities of SOPROL and the broader Safety Operations team with the goal of supporting high quality scientific decision-making and agility in cross-functional partnerships.

• Manages audit and inspection preparedness in support of PSTs. Prepares Portfolio Leads and Product Managers for product SME direct participation in front and back rooms.

Represents VP Safety Operations in senior leadership scientific discussions on assets. Serves on GPS scientific governance bodies as needed

Performs SOPROL responsibilities for sensitive or confidential assets (e.g. related to acquisition deals and company partnerships)

Qualifications :

Minimum: Bachelors degree with related health sciences background; Licensed healthcare professional preferred. RN BSN BS BS Pharm PharmD or advanced degree preferred.

At least 6 years experience working in the healthcare industry and a strong understanding of the drug development process.

• A previous Pharmacovigilance leadership role preferred.

Minimum 3 years of clinical development experience

4 years of pharmacovigilance experience required

Demonstrated ability to collaborate with internal and external stakeholders such as Affiliates Health Authorities and third party vendors preferred

Significant experience leading cross-functional teams on complex projects required

Significant experience in directly leading and driving major change initiatives within a team.

Strong leadership presence and demonstrated ability in courageously challenging the status quo and influencing others. Experience in working directly with and influencing senior management.

High emotional intelligence strong relationship management and communication skills.

Understanding of the connections between regulations and science for the benefit of drug safety

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time