The primary job functions for this position include human safety surveillance related to pharmaceutical products and medical devices and risk identification and assessment. The analysis and interpretation of large amounts of safety data in specific therapeutic areas will be paramount, as will the written and oral communication of said analyses. The effective functioning of product safety teams in an important responsibility.
- Define, lead and execute the safety strategy within ADTs/ GMATs/ PSTs for products for which he/she is functioning as the PST lead.
- Contributes to the strategy and authorship of key pharmacovigilance documents including but not limited to White papers, regulatory responses, risk management plans and the components of the BRPA.
- Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
- Safety Surveillance and Risk Identification and Assessment Risk Management - Apply current regulatory guidance for risk minimization to AbbVie's product safety, RMP/REMS plans, as appropriate.
- Lead and implement the risk management strategy for assigned products.
- Understand assigned products' pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile.
- Knowledge of clinical AE profile ranges from familiarity with individual case safety reports for assigned products to comprehension of aggregate safety data across clinical trials.
- Responsible for the mentorship of colleagues on PST both on product knowledge but additionally on the safety strategy for pharmacovigilance.
- Responsible for execution of surveillance and signal detection for assigned products in collaboration with Aggregate safety and Medical analytics.
- MD, DO or equivalent degree is required
- A minimum of 2 years experience in drug safety within the pharmaceutical industry
- Residency with direct patient management and care of patients is preferred
- Board eligible or board certified is preferred
- Clinical development or clinical research experience is preferred