Pharmacovigilance Manager - Raleigh, NC
SRG is looking for a Pharmacovigilance Manager for our client based out of Raleigh, NC. This is a brand new, full time, permanent position that will allow this person to oversee the whole PV process.
- Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, and line listings author responses to regulatory agency inquiries, as required.
- Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
- Assist with Signal Management activities on post-marketing and clinical trial projects. Organize and assist with adverse event line listings for ongoing signal detection activities as per agreed signaling strategies, signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Responsible for documentation and retention of all adverse event listings used for aggregate safety review.
- In a PV support role, participate in and QC review safety responses to regulatory agencies and justification documents to support labelling documents.
- Maintaining electronic archive of safety reports, outcomes, imaging requests, etc. on clinical database.
- Interface with external vendors and other functional groups and other business units, such as Regulatory Affairs, Safety, Clinical Research, Quality, Project Leads (PL), Medical Affairs and Information Technology (IT), as needed.
- Participate in internal and external audits and inspections, as required.
- Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
- Support and/or contribute to technology / innovation activities.
- Oversee vendors on training program.
- Assist with coordination and management of Interventional Proceduralist Network.
- Aid in management of DSMB and iDMC activities.
- Assist with investigator brochure and ICFs updates.
- Participate in interdepartmental activities as necessary.
- BS / RN degree with 3-5 years of experience or
- MS / PharmD / PhD / MD with 1-3 years of experience
- GCP experience / training and GVP / ICH experience
- iCSR experience (amongst other reports)
- Experience with audits
- Team Player
- Pharma industry experience
- PV / Drug Safety experience
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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