We want to help make extraordinary things possible for patients. We are inspired by their stories, and it is our mission to accelerate innovations that enable better outcomes. Every day, we work alongside customers and partners to unleash potential and help improve health around the world. We deliver on our mission by helping to speed drug development, ensuring product quality and safety, improving commercial effectiveness, getting the right treatments to patients, improving access and delivery of healthcare, and ultimately driving better health outcomes. And we always strive to be extraordinary – every step of the way.
Role: Signal Management System (RMP)
Project Role: Signal Management System (RMP)
Management Level: G140/G150/160
Qualification: B.Pharam, M.Pharm, M.Sc, Pharm.D, BDS, MDS, BAMS & BHMS
Experience: 05-15+years
Job Location: Ahmedabad, Gurgaon/Gurugram, Bangalore/Bengaluru, Mumbai
Professional Attributes: 1) Good communication skills 2) Excellent analytical skills 3) Team player (As per business mandate and role)
Roles and Responsibilities
- Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survelliance projects.
- Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings
and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. - Act as literature lead, back-up lead, reviewer/QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
- Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products’ signaling strategies. Oversee/author and/or QC review all types of signal management deliverables.
- Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections.
