Pharmacovigilance Product Safety Lead

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. 

1. Provide appropriate inputs to key strategic safety discussions to ensure success of development products and on market benefit/risk assessments.
2. Leverage expertise in local regulations to provide strategic direction for PV/device submission/approval & regulatory questions.
3. Offers expertise as necessary for creation of safety deliverables and at any local Health Authority review boards/meetings if needed.
4. Triage and translate affiliate product safety information needs to PPS Safety Science subject matter experts and ensure closed loop on information needs. Anticipate product safety information valuable to development assets.
5. Facilitate Affiliate medical teams’ understanding of benefit-risk position/messages and critical insights (e.g. safety topics discussed during dialog with regulatory agencies, post-marketing safety studies). Ensure readiness to implement post-marketing safety commitments.
6. Facilitate timely connection between Safety Science subject matter experts with Affiliate teams partnering with PPS to maximize success of development programs and regulatory filings and on market assets.
7. Liaise with affiliate/area cross-functional teams to proactively gather insights on regulatory and commercial strategies for development and late stage assets and provide PV/clinical safety expertise. Evaluate impact of these strategies on risk management planning and PV deliverables/activities. Connect with PPS and affiliate PV Teams to share relevant information and ensure readiness to support strategies.
8. Present product safety information at key affiliate, regional and global leadership meetings and provide appropriate local context to inform local business decisions/activities.
9. Share local safety insights with PPS Safety Science leaders to ensure these are considered within the context of Global PV strategies.
10. Facilitate best practice sharing across Area PV Product Leads and more broadly, across the International PV and PPS organization.

Required Education:
 Bachelor’s degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines), Masters or advanced degree is desirable.
Required Experience:
• At least 7 years’ experience working in the healthcare industry and a strong understanding of the drug development and drug licensing process.
• Extensive experience within Pharmacovigilance in Medical Safety is required (e.g., Medical Safety Physician). Comprehensive knowledge of PV/Medical Safety activities and deliverables, throughout the product lifecycle, required to support and maintain product benefit-risk profile.
• Ability to understand product’s safety profile and put this into local medical context to anticipate and mitigate potential safety considerations and issues.
• Understanding of the connections between regulations and science for the benefit of drug safety
• Strong leadership presence and strong communication/presentation skills.
• Proven ability to effectively communicate and synthesize pertinent information, in a clear and impactful manner, to senior executives.
• Ability to connect the dots quickly between strategies and decisions; Skilled in asking the right questions and proactively anticipating information needed to inform business decisions/actions.
• Ability to work collaboratively with colleagues across organizational boundaries.; Ability to quickly build trusted relationships in affiliates, at a regional/area level, across therapeutic areas, etc.
• High degree of strategic thinking and demonstrated problem solving skills; Resourcefulness and initiative to access/find information; Ability to think quickly on his/her feet.

AbbVie is an equal opportunity employer and 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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html