Drug Safety Associate - KAI Research
KAI Research, an Altarum company, is recruiting for a Drug Safety Associate to work in the Rockville, MD office. The Drug Safety Associate monitors and evaluates the safety of investigational and marketed drugs for pharmaceutical clients. Provides medical or clinical consultation to clients, study sites and internal departments. Works with limited supervision and is responsible for developing, directing, coordinating, and administering policies and procedures relating to all phases of medical affairs.
- Investigates, evaluates, and follows up on case reports associated with safety of investigational and marketed drugs.
- Reviews medical and scientific literature for reports of adverse events.
- Performs coding of adverse drug experiences using MedDRA and drugs using the WHO Drug Dictionary.
- Prepares expedited and periodic case reports for marketed drugs (NDS/ANDAs) for submission to the FDA.
- Gathers complete SAE information and prepares expedited case reports associated with investigational new drugs (INDs) for FDA submission and dissemination to study sites.
- Contacts study sites for follow-up information on clinical SAE cases.
- Participates in SAE reconciliation between the safety and study databases.
- Reviews study protocols, final study reports and other safety related documents.
- Provides guidance in handling and processing SAEs to clinical study sites.
- Responds to product safety queries.
- Participates in clinical team meetings and other safety related meetings.
- Communicates with clients regarding project issues regularly
- Handles incoming calls, facsimiles and email from healthcare professionals, the general public and others to answer specific questions pertaining to pharmaceutical products
- Performs literature searches using Pubmed and other databases to help answer questions received by healthcare professionals
- Reads and reviews scientific literature related to supported products such as books, manuscripts, publications and marketing communications
- Updates standard responses on a regular basis
- Maintains product information programs as needed
- Identifies calls pertaining to adverse events and product complaints and triages those calls as appropriate
- Performs other assigned duties as required
- Degree in Nursing, Pharmacy, medical field or other allied healthcare field
- Two- three years’ experience in drug safety in the pharmaceutical industry or other comparable experience
- Experience in medical care and clinical operations
- Must be able to function independently and as a team member
- Ability to execute assigned tasks and meet assigned milestones
- Knowledge of FDA and ICH regulations related to drug safety
- Ability to build and maintain good working relationships with clients, patients and healthcare professionals
- Excellent oral and written communication skills
- Good organizational and time management skills
- Proficient in word-processing, database and spreadsheet software
ABOUT KAI RESEARCH:
KAI Research's dynamic work environment emphasizes integrity, personal commitment, and teamwork. In addition to the meaningful and challenging work, KAI offers an outstanding benefits program that includes paid time off, tuition reimbursement, 401k (5% employer contribution), a flexible work environment, and much more. We invite you to explore exciting and rewarding career opportunities with us.
KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability
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