Senior Safety Associate II (Adverse Events of Special Interest, Global Pharmacovigilance)
Cambridge, MA 02142 US
The Global Safety and Regulatory Science (GSRS) Adverse Events of Special Interest (AESI) Associate is accountable for the identification, evaluation and management of all incoming Individual Case Safety Reports (ICSRs) of events of special interest (AESIs) identified by GSRS. The Associate is accountable for timely key clinical and operational decisions using sound clinical and pharmacovigilance (PV) judgement, and concise communications with internal and external stakeholders on ICSRs of interest through case triage, case assessment, and case query administration. The Associate supports GSRS AESI Team leadership in the operational management and oversight of AESI case processing activities outsourced to a vendor, ensuring all AESI case processing is conducted in compliance with regulatory requirements and procedures. The Associate will support company initiatives to advance the understanding of the safety profile of our products.
Outline of Key Responsibilities:
- Triage of all incoming initial and follow-up AESI reports
- Evaluation of the existing clinical data points and generation of relevant follow-up queries for all reports of AESI using clinical knowledge, PV experience, and communication skills within predetermined timelines
- Collaboration with affiliate/distributor/and associated external AE collection partners for follow-up queries in Rest Of World locations.
- Direct administration of queries with healthcare providers in the US.
- Collaboration with field staff (MSLs, ABMs) to gather relevant clinical data
- Presentation of the AESI clinical data to the adjudication committee
- Documentation and dissemination of key decisions to stakeholders
- Achieve and maintain compliance with oversight activities for internal and external partners including, but not limited to, performing Quality Review in the global safety database and oversight of follow-up activities conducted by partners on behalf of GSRS.
- Support the development and delivery of training material to Case Processing Vendors, the affiliates and distributors, Patient Services and Field Staff
- Performs Late Case Investigations and provides Subject Matter Expertise on AESI ICSR Management
- Generation and Quality Check of routine periodic regulatory reports
Essential Skills and Qualifications:
- Solid understanding of worldwide post-marketing and clinical trial adverse event regulations including GCP, CIOMS, EMA, GVP
- Strong ability to understand, evaluate, and succinctly summarize complex technical, scientific and medical information
- Ability to work and communicate effectively in a collaborative team environment
- Excellent organizational skills with an ability to embrace change and multi-task in an extremely fast-paced environment
- Critical thinker with an aptitude for generating solutions
- Ability to solve complex problems, produce clear and concise documentation
- Good computer skills and ability to learn new systems as they are implemented
Education and Experience Requirements:
- Minimum of bachelors level degree in nursing, pharmacy or other health related profession
- 3+ years in clinical setting preferred but not required
- 2+ years in Pharmacovigilance/ Drug Safety
Salary will be commensurate with experience
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