THE POSITION:
This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources.
OUR CULTURAL BELIEFS
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Embrace Diversity I create an environment of awareness and respect.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Own It I hold myself and others accountable for results.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
- Plays an essential role supporting PV Operational Delivery to facilitate and meet client project deadlines for various aggregate and signal reports, line listings, and safety data compilation as required by client.
- Manages the operational aspects of aggregate safety reporting. Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of a range of global regulatory aggregate safety reports to include Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Annual Safety Reports (ASR), and IND Annual Reports and client specific signal detection reports.
- Lead, author and finalize aggregate reports and cumulative, or ad hoc, line listings as required to meet regulatory requirements and contracted deliverables for client projects
- Support the authoring and editing of RMP, PSMF, and/or other PV risk management documents in collaboration with PV safety science, PV operational leadership, and PV Project Management
- Collaborates with various stakeholders to ensure that outputs from the safety database meets the need for preparation through submission of aggregate safety reports, while maintaining compliance with regulatory timeline(s).
- Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety management plans (SMP), and safety data exchange agreement(s) (SDEA) / Pharmacovigilance Agreement(s) (PVA).
- Knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements.
- Experience interacting with sponsors/clients and health authorities (e.g., audits, inspections, responses) and CAPA management process(es).
- Experience in interpreting, synthesizing, and communicating complex safety information.
- Experience with safety database(s) (e.g., ARGUS, ARISg) and MedDRA.
- Experience with the development and maintenance of procedural documents (i.e., standard operating procedures, work instructions, templates, forms).
- Participates in cross-functional teams to create/refine policies to develop and promote best practices, processes, identify new tools, and develop new policies to promote consistent aggregate reports excellence, monitor performance trends and drive continue process improvements related to aggregate reports.
- Strong attention to detail with a proactive persistence approach to following tasks through to completion. Working with clients/sponsors, clinical research organization(s) (CRO), vendors, and license partner(s). Proficiency with standard office software (Microsoft Office [i.e., Word, Excel, PowerPoint]) and formatting documents.
- Support PV Operations, PV audits and inspections
- Draft other safety writing deliverables as needed
- All other duties as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
EXPECTATIONS OF THE JOB:
- Responsible to deliver CLIENT DELIGHT
- Responsible to identify, deploy, oversees, mentor direct reports and consultants supporting various clients
- Responsible to work collaboratively with EVERSANA PV team and take direction and feedback from management and clients
- Responsible to ensure management and compliance with industry standards and codes of practice
- Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical, and compliant medical content
- Responsible to proactively flag and manage any quality issues, and ensure timely corrective and preventive actions
- <5% Travel
- Average 40-45 hours/week
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
An individual in this position must be able to successfully perform the expectations listed above.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
- 3-5 years of relevant experience, which includes 0-3 years in drug safety and 1-3 years of aggregate report writing for specialist, >3 years for manager
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Strong attention to detail, teamwork, and initiative
- Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
- Familiarity with FDA and international adverse event reporting regulations per ICH guidelines
- Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus
- Must be quality oriented and demonstrate consistent attention to detail
- Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
- Must have good planning and organizational skills
- Knowledge of relevant software including safety database and Microsoft Office
PREFERRED QUALIFICATIONS:
- Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others, and a sense of humor. Energizes others and heightens morale through her/his attitude.
- Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
- Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
- Highly Principled – Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.
