THE POSITION:
This role supports the Pharmacovigilance (PV) Department by leading the planning and delivery of key safety documents, including PSURs, PBRERs, RMPs, and other risk management materials. Responsibilities include compiling safety data from clinical trials and post-marketing sources, driving project execution, and gradually taking on team oversight as the role expands.
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 aggregateand signal reports,line listings, and safety data compilation as required by client.
- Manages the operational aspects of 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), IND Annual Reports; Risk Management Plan (RMP) 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 review of RMP, PSMF, and/or other PV risk management documents in collaboration with 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, review 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.
- Aggregate report writing training and mentoring for new individuals.
- Being proactive in tracking status of aggregate reports across all projects and chasing comments from clients and authors to ensure submission of aggregate reports within stipulated timelines.
- Assist in maintaining aggregate schedule and allocation of reports.
- Liaise effectively and maintain excellent relationship with the clients and external contacts.
- Support PV Operations, PV audits and inspections
- Draft other safety writing deliverables as needed
- Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
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
- 4-7 years of relevant experience, which includes 0-3 years in drug safetyand 4-5years of aggregate report writing for specialist, >6 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
