Product Safety Lead

Responsible for all tasks related to the collection, processing, follow up and regulatory reporting of adverse events (AEs), serious AEs from Clinical Trials (SAEs), adverse events of interest (AEIs) and pregnancy reports for all marketed and investigational products. This position will routinely process all types of reports for all categories of products (medical device, cosmetic and OTC products).

Responsibilities
Post Marketing Adverse Event Processing

• Ability to independently analyze and accurately process adverse event reports from all sources, for medical devices, cosmetics and OTCs. This includes an ability to provide an assessment of complex medical information and relevant lab results, and the ability to enter the report in the safety database, write comprehensive narrative summaries, and conduct follow-up for all types of products.

Clinical Study SAE Processing

• Actively participates in internal clinical project teams and provides input regarding the collection of adverse events during the conduct of clinical studies. Develops and maintains the safety sections of clinical trial protocols and Investigator Brochures (IBs). Writes Safety Management Plans as required. Participates in all safety related end-of-study activities such as SAE reconciliation. Enters the report in the safety database, writes comprehensive narrative summaries and conducts follow-up as required.

On Time Submission of AE Reports

• Ensures on time submission of individual AE and SAE case reports to worldwide regulatory agencies, partners, and affiliates in accordance with applicable regulations and agreed timelines. Ensures that company obligations with respect to Safety Data Exchange Agreements (SDEAs) are fulfilled in an appropriate and timely manner.

Evaluation of Individual AE Reports and Safety Data

• Evaluation of individual case reports considering medical/pharmacological aspects as well as verification of MedDRA/IMDRF coding for adverse events (clinical signs), problem codes impact on health, examination findings, cause evaluation. Conducts medical review and assessment on individual AE case reports. Maintains general knowledge of signals, trends, and closely monitored events. Communicates any potential safety issue appropriately. Able to make clinical judgments regarding whether or not an individual report meets clinical/regulatory criteria for expedited submission to Health Authorities.

Literature Reviews

• Execute, review and document periodic and ad-hoc reviews of the biomedical literature to identify novel or reportable individual safety case reports / safety signals.

Safety Database Proficiency

• Able to effectively use industry-standard, validated product safety database. Proficiency with data entry, process flow, query and report generating functions are essential. Creates draft reports/data tables to fulfill regulatory agency or notified body queries, or upon request of management. Performs searches of the safety database for internal compliance or other ad hoc queries as required.

Review and Update of Departmental Documents

• Assists in development, review, and implementation of Global Device Vigilance working practices, standard operating procedures (SOPs), or guidance documents to ensure compliance with international regulations governing clinical safety and device vigilance for adverse event reporting.

Provides Training Regarding AE Reporting

• Provides training to clinical investigators, sales representatives, other employees, and contractors in their obligations regarding adverse event reporting. May assist with orientation/mentoring of new Product Safety staff.

Audit Support

• Participate in all internal and external audits as needed.

Supports Regional Safety / Vigilance

• Supports regional, non-US Safety staff as needed to ensure compliance with vigilance requirements in ex-US markets.

Collaborate with Other Global Functions

• Cooperative interaction with non-Safety representatives across company business units such as Quality, Clinical, Regulatory, and Medical Affairs.

Technical & Functional Skills

• Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed products – both drugs and medical devices.
• Strong knowledge and experience with validated safety databases (Argus, ARISg, SIAB, etc.). This also includes MedDRA, WHODrug, and IMDRF coding.
• Must work effectively/collaboratively in a fast-paced yet efficient team environment with individuals at all levels within an organization.
• Strong knowledge of FDA and EU regulations governing clinical safety and vigilance.
• Strong organizational and project management skills.
• Strong verbal and written communication skills.

Minimum Qualifications

• Bachelor’s degree in a science or health care-related field or RN/PharmD
• 5+ years of experience in drug safety or medical device vigilance (preferred) in an industry setting or equivalent

Preferred Qualifications

• Direct health care experience with injectable products highly desired
• Knowledge and experience with document management systems (EDMS, eTMF, etc.)
• Experience in vendor management
• Demonstrates relationship building and problem-solving skills

Pay Rate Range: $40-45/hr