Drug Safety Associate - Pharmacovigilance
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization committed to treatment and development for central nervous system disorders, cardiovascular and digestive diseases, cancer, respiratory and dermatology conditions and provided a range of clinical, nutritional and diagnostic products. Our client is looking for a highly qualified and skilled professional for the role of Drug Safety Associate in Princeton, NJ. Position will be responsible for supporting Pharmacovigilance management in the maintenance and creation of departmental procedures including but not limited to Standard Operating Procedures (SOPs), Pharmacovigilance and Safety Agreements, data entry conventions for the drug safety database (as distinct from the clinical database(s), work processes and drug safety database procedures.
- Case Processing and support as a SME for MedDRA coding
- Independently responsible for performing and overseeing various aspects of the ICSR process as assigned by Pharmacovigilance department management
- Responsibilities may be functional as well as product specific at the discretion of Pharmacovigilance management
- May serve as a SME in certain aspects of ICSR handling, this includes interactions with external contract service provider(s) involved in the receipt, processing and management of drug safety information, reconciliation activities, and product complaints associated with adverse events
- Perform and/or oversee the collecting, documenting, and processing of adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance. This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check
- Supports management as SME for ICSR handling during Pharmacovigilance related regulatory inspections or internal quality assurance/corporate compliance audits
- Management and oversight of Pharmacovigilance vendor(s)
- Support Pharmacovigilance management in the oversight of vendor supported ICSR processing
- Assist Pharmacovigilance Management in the oversight of deliverables related to ICSR case handling and calls for contributions for periodic reports including but not limited to line listings, annual safety reports (ASR), development safety update reports (DSUR), Periodic Safety Update Reports (PSUR/PBRER/PADER), Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS) and other reports from the Drug Safety database
- Supports Pharmacovigilance Management in the maintenance and oversight of external pharmacovigilance providers (i.e., compliance with SOPs and regulatory obligations in compliance with national and international regulations, such as FDA, ICH, EU, global, regional and country regulations for the reporting of adverse events to regulatory agencies)
- ICSR data quality
- Participate in the collection of quality data related to ICSR handling
- Support the generation of monthly quality metrics and other KPIs as required
- Support Pharmacovigilance management in investigation, root cause, corrective and preventive actions related to internal and external Pharmacovigilance associated CAPA findings
- Attend vendor meetings and liaise with vendor management and governance bodies as required in support of ICSR related outsourcing activities
- 2-4 years drug safety experience in US Pharma company, (neither CRO, Consumer Health nor Cosmetic experience alone is sufficient)
- Must have sufficient experience and a demonstrated knowledge and understanding of ICH guidance as well as FDA, & EU Regulations and Requirements for Pharmacovigilance
- Must have a working knowledge of global safety reporting regulations and guidelines
- Requires a solid understanding of medical and clinical practices, with a strong understanding of medical concepts and terminology
- BS/BA* in healthcare professional field (e.g. RN, BSN, RPh) + 2 yrs. safety experience
- MS/MA + 3 yrs. relevant experience** (2 yrs. safety experience)
- PharmD + 1-2 yrs. relevant experience (1 yr. safety experience) For PharmD, a one year residency or fellowship can be considered relevant experience
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.