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Pharmacovigilance safety expert skills for your resume and career
9 pharmacovigilance safety expert skills for your resume and career
1. Safety Data
Safety data is a document that lists information related to occupational safety and health for the use of substances or products.
- Ensured that appropriate data was entered correctly and precisely in Clinical safety database according to departmental standard operating procedures.
- Influenced marketing team to integrate relevant safety data collection in the patient support programs.
2. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Case triage, maintain multiple trackers, Assist in QC role, Assist in report approval role
- Performed secondary QC of processed cases; assist with retrospective QC and SAE reconciliation.
3. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Prepared department to be inspection ready by participating in internal audits and maintaining familiarity with FDA and EMEA required documentation.
- Completed risk based inspections in food service establishments based off of FDA guidelines Investigated food-borne illnesses and consumer complaints
4. Safety Culture
Safety culture is a set of individual and group values, perceptions, attitudes, ways of conducting, and beliefs that employees share about risks within an organization. It is an organizational culture that prioritizes the safety beliefs, values, and attitudes that the majority of people in the organization share.
- Changed safety culture from being reactive to proactive, established and tracked monthly safety goals.
- Developed a safety incentive program to encourage use of personal protective equipment and to foster a group-minded safety culture.
5. Clinical Trials
- Analyzed the data from non-Interventional clinical trials.
- Identified global regulatory reporting requirements especially for Gilead sponsored clinical trials reports and communicate them effectively with the submissions group.
6. Argus
Argus is a systems and network monitoring application. It is devised to supervise the position of servers, network services, and network hardware. It works by sending alerts when a problem is detected. The software improves the flow and visibility of information throughout critical business processes.
- Performed adequate duplicate search in database prior to book-in and creating cases in Argus.
- Process Spontaneous, Post Marketing and Clinical Trial Adverse Event reports in Argus.
7. Drug Safety
- Reported and provided drug safety documents to appropriate client or FDA for regulatory submission for advisory committee review.
- Developed drug safety presentation for investigator meetings.
9. Sops
A standard operating procedure or simply SOP is a particular operation that needs to be done in accordance with the rules and guidelines of a company or an industry. It is an important way for a company to run smoothly, especially in small businesses. It is like a practice wherein everything an individual or an employee is under a particular standard that is implemented.
- Trained and mentored peers in case processing methodologies, as per regulations and local SOPs.
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List of pharmacovigilance safety expert skills to add to your resume
The most important skills for a pharmacovigilance safety expert resume and required skills for a pharmacovigilance safety expert to have include:
- Safety Data
- QC
- FDA
- Safety Culture
- Clinical Trials
- Argus
- Drug Safety
- Health Authority
- Sops
Updated January 8, 2025