Sr. Pharmacovigilance Specialist

Location
San Francisco, CA, United States
Posted
Nov 04, 2018
Ref
3287-515-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Overall responsibility for supporting the drug safety and pharmacovigilance (PV) process.

Overall responsibility for supporting the drug safety and pharmacovigilance (PV) process, including management of external partnership for safety data exchange, PV quality and inspection readiness, maintenance of department Standard Operating Procedures, development and maintenance of Safety Management Plans (SMPs), and coordination of preparation of aggregate safety reports and safety risk management process.Specifically, this position will interface with internal and external collaborators/business partners/CROs/vendors to develop programs and processes to meet regulatory reporting requirements and facilitate safety signal detection/risk management activities. Supports the negotiation, preparation, review and renewal of Safety Data Exchange Agreement (SDEA) and/or PV Agreement (PVA) by working with external development partners/license partners and internal stakeholders.Manages compliance with SOPs and FDA and international regulations for the reporting of adverse events to regulatory agencies. Interfaces with GCP&QA Compliance on drug safety and pharmacovigilance quality issues to insure quality events are resolved in a timely manner, and facilitates the preparation, conduction and follow- up of regulatory authority inspections as well as internal and external PV audits.Coordinates the development and preparation of periodic safety reports (e.g., DSUR) and other reports as necessary.

Develops and maintains the templates and author/reviewer metrics for the periodic safety reports. Authors and coordinates the development and preparation of protocol-specific safety management plan (SMP) to ensure appropriate handling of safety data collection and reporting at protocol level. Monitors metrics for adherence to data exchange per SDEAs/PVAs with collaboration partners and distribution to vendors and investigators, as required for per SMPs. Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Acts independently to determine methods and procedures. Perform standard quality check of data entry of serious adverse events or other documents as requested. Promptly escalate study site non-compliance with request for outstanding information, to the appropriate senior drug safety personnel within Nektar. Root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. Initiate corrective and preventive action (CAPA) measures following review of root cause analysis with senior drug safety personnel. Maintain and track all CAPAs related to Nektar Drug Safety. Support Drug Safety Department initiatives on ad hoc (as needed) basis. Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally. Ensure compliance with Nektar's SOPs. Supports the negotiation, preparation, review and renewal of Safety Data Exchange Agreement (SDEA) and/or PV Agreement (PVA) by working with external development partners/license partners and internal stakeholders.Coordinates the development and preparation of periodic safety reports (e.g., DSUR) and other reports as necessary. Develops and maintains the templates and author/reviewer metrics for the periodic safety reports. Authors and coordinates the development and preparation of protocol-specific safety management plan (SMP) to ensure appropriate handling of safety data collection and reporting at protocol level. Monitors metrics for adherence to data exchange per SDEAs/PVAs with collaboration partners and distribution to vendors and investigators, as required for per SMPs. A Bachelors degree in a scientific discipline is required. Working experience as a health care professional (Pharmacist/PharmD, RN, PA) is highly desired. Equivalent experience may be accepted.

A minimum of 7 years experience in Drug safety or Pharmacovigilance, with at least 4 years hands-on experience in adverse event management in clinical trials evaluating investigational products is required. An in-depth knowledge and thorough understanding of FDA and EU regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases and preparing aggregate safety reports (DSUR, PSUR/PBRER/PADER) is required. Experience in oncology therapeutic area is preferred but not mandatory. Familiarity with medical terminology required. Ability to prioritize work without much support. Clear and effective written and verbal communication skills are essential for effective communication with study sites. Focused and detail oriented. Work effectively as a team member, promote collaboration. Self starter and self accountability. Relevant industry experience is highly preferred. Must have strong computer skills with a proficiency in various software applications (e.g. Microsoft Project, Word, Excel, PowerPoint). High level of work conduct.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.