Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
This position reports into the Safety Operations Product Leadership team which is part of the Safety Operations function in Pharmacovigilance and Patient Safety (PPS). The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients worldwide. Safety Operations oversees the intake, processing, and reporting of patient safety information.
This position is accountable for delivering Safety Operations scientific input and expertise for assigned AbbVie assets in development or on market. The Safety Operations Product Specialist drives high quality Safety Operations deliverables and decisions through strong product knowledge, understanding of the product strategy, pharmacovigilance and clinical development expertise and interpretation of current global regulatory requirements.
Responsibilities:
The Safety Operations Product Manager is the single point of accountability for the accuracy, timeliness and completeness of all Safety Operations activities and deliverables related to assigned assets, including:
• Partners with the Product Safety Team (PST) to provide input on study protocols, Urgent Safety Measures/Unanticipated Problems (USM/UP), animal and toxicology reports, global regulatory agency requests, and inspection support.
• Collaborates with Clinical Trial Patient Safety (CTPS) for investigator brochure (IB) and protocol support.
• Supports new product launches by ensuring New Drug Applications (NDAs) are added to the Company Product Dictionary (CPD), product training, and oversight of the product throughout the lifecycle.
• Supports Safety Operations Portfolio Lead in the contextualization of Adverse Event data (from an ICSR perspective) for assigned products.
• Participates in audits and inspections. Prepares materials related to Adverse Event data and decisions, as it relates to product strategies. Engages in front-room interviews. Supports PST Leads, International PV Network and other stakeholder groups in preparation for audits and inspections.
• Functions as the Safety Operations asset lead for compounds from discovery through approval for the life of the product. Supports all types of studies including phase I through phase IV, Postmarketing Observational Studies (PMOS), Investigator Initiated Studies (IIS), and collaborations studies.
• Determines when PV blind breaks should be processed for end of study blind breaks. Functions as a blind break decision maker for blind breaks due to safety concerns and health authority requests.
• Liaises with Global Medical Affairs (GMA) on GMA sponsored studies by providing input on safety data collection and protocol and contract review to ensure safety language is correct and in compliance with the global regulations.
• Develops Knowledge Management Tools (KMTs) and specific protocol trainings for clinical case processing resources. Collaborates with PV Partnership for Safety Data Exchange Agreements (SDEAs) for both clinical compounds and approved products.
• Provides input to Safety Operations ICSR forecasting process by providing relevant productspecific insights on studies (planned, active, completed), regulatory commitments and filings, anticipated approvals/launches, Patient Support Program strategies, etc.
Qualifications
Qualifications:
• Bachelor’s degree with related health sciences background; Licensed healthcare professional required. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.
• At least 4 years experience working in the healthcare industry and a strong understanding of the drug development process.
• 3 years of pharmacovigilance experience required
• Strong understanding of case processing and the current global regulatory requirements that impact PV
• Strong leadership presence and communication skills
• High emotional Intelligence and strong relationship management and communication skills
• Demonstrated ability to collaborate and influence cross-functionally and globally
• 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.
- This job is eligible to participate in our long-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
