Our client, located near San Francisco Bay Area is seeking a Sr. Drug Safety Associate for an immediate full-time position.

Details include:

The Senior Drug Safety Associate (DSA)

:

Establishes work priorities and direction independently with minimal input from Manager.

Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure maintain regulatory compliance.

This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.

Prepares clinical narrative summaries for AE reports independently from clinical studies and spontaneous post-marketing reports and formulates follow-up information requests.

May perform active follow-up via telephone contact with consumers and health care professionals.

May work with Clinical Research Department and Contract Research Organizations, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.

Codes all AEs in MedDRA independently.

Ensures timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s).

·

Participates in the preparation of aggregate safety reports, such as quarterly safety reports to Ethics Committees and annual reports to regulatory authorities.

·

Conducts periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervisionRepresents the DSRM department on project teams.

Completes individual projects in support of DSRM department initiatives

Requirements:

Health care professional degree (PharmD, RN, MD) with at least 3 years drug safety experience AND additional clinical or pharmaceutical experience, or a BS or MS degree with at least 5 years in the area of drug safety or 3 years in drug safety with additional applicable experience.

Strong verbal and written communication skills demonstrated by the ability to interpret and communicate medical information and write summary reports, if needed.

Strong interpersonal skills especially for proactive drug safety representation on clinical/project team and investigator meetings, and communications with contract research organizations (CROs) involved in safety reporting.

Candidate must have the ability to organize workflow activities, able to multi-task, be performance-driven, and possess good decision-making skills.

Computer literacy including working knowledge of computer applications such as word processing, spreadsheets and electronic mail is required; experience with data entry into drug safety databases strongly desired; ARISg experience a plus.

Knowledge of domestic and international drug safety regulations, industry practices and standards as well as clinical knowledge in appropriate therapeutic area is preferred.

Must have experience writing safety narratives.



Headquartered in Princeton, New Jersey, clinicalBROKERS is a full service staffing solutions company dedicated to providing qualified technical professionals to our clients. clinicalBROKERS provides Consulting/Contract, Contract to Hire, Full Time Permanent, and Project Outsourcing Solutions. Our thorough candidate pre-screening process allows us to present the most qualified professionals for any staffing need.

Our success is a result of strong client partnerships where we have a solid understanding of our clients corporate structure and how our candidates can contribute to their business. In addition, our solid relationships with our candidates allow us to find the best suited environment and opportunity for each individual.

Our consultants select us for the personal touch and thorough understanding of what a professional needs. They prefer to work with a company that prides itself in working with only the best people in the highest ethical manner. They know we strive to find for them the best opportunity full of exciting challenges, experience and most importantly, an opportunity to advance their career.

Employees of OUR CLIENT are committed to creating and maintaining an environment that values hard work, fosters creativity, and promotes success.

OUR CLIENT a professional work environment, fueled by the talent and expertise of our employees, and driven by our commitment to the prevention and treatment of world health problems. Here at OUR CLIENT, a competitive compensation and benefits package and are committed to creating and maintaining an environment that values hard work, fosters creativity and rewards success. Our professional work environment is fueled by the talent and expertise of our employees, and driven by our commitment to the prevention and treatment of world health problems.

Medical, Dental and VisionOUR CLIENT offers three medical plans to choose from, a Premier Delta Dental Plan, and a PPO Vision Service Plan. Plans are offered to all eligible employees and their eligible dependents, including Spouses, Domestic Partners and Children under the age 19 (unless full-time student). All plans are effective date of hire. Dental and Vision plans are offered at no cost to the employee.

Short-Term DisabilityShort-Term Disability - provides eligible employees (after 7 day waiting period) with 66 2/3% of monthly salary to a maximum weekly benefit of $3,462 for up to 12 weeks.

Long-Term DisabilityProvides eligible employees disabled more than 12 weeks with 66 2/3 of monthly salary to a maximum of $15,000 per month benefit to age 65

.

Group Life and Accidental Death and DismembermentCoverages are offered at no cost to the employee. The benefit level is two times annual salary up to a maximum of $500,000.

Voluntary ProductsUniversal Life, Critical Care and Long-Term Care are coverage available for employees who want added protection for themselves or their family members. Employees may purchase any or all of these products through convenient payroll deductions.

401(k) Savings PlanEmployees may participate in the 401(k) plan upon date of hire and may designate pre-tax contributions from 1% to 100% of salary, not to exceed the maximum annual state limit. OUR CLIENT will match up to 50% of the first $6,000 contributed.

Tuition Reimbursement ProgramReimburses 100% of costs, up to $1,000 per calendar year, for tuition, books, and lab fees for courses related to your career, after six months of service. You will be eligible for reimbursement if the course has been satisfactory completed with a grade C or better.

Employee Stock Purchase PlanEmployees may allocate up to 15% of their after-tax earnings to purchase OUR CLIENT stock at 85% of its fair market value during certain times of the year. Amounts contributed to this plan will be withheld from each paycheck before the actual purchase takes place.

Flexible Spending AccountsOUR CLIENT offers health care and dependent care reimbursement accounts to all eligible employees. With these accounts, employees have the option to set aside pre-tax dollars to pay for eligible out of pocket heath and dependent care expenses.

529 College Savings PlanOUR CLIENT offers a tax-advantaged way to save money for your own or your childrens college education through the 529 College Savings Program. A 529 Plan allows you to invest up to $11,000 a year per parent per child to help pay for college.

VacationEmployees accrue 10 hours of vacation per month, up to three weeks per year.

Sick TimeAll regular full-time employees are allowed 10 sick days per year. If hired before June 30th, employee is allowed 10 sick days for that year; if hired after June 30th, employee is allowed 5 sick days that year.

HolidaysOUR CLIENT provides a total of 9 paid holidays each year, 7 scheduled and 2 floating.

Leave of AbsenceOUR CLIENT may grant leaves of absences to accommodate employees medical, maternity, family or personal needs.

AnniversaryEmployee anniversary recognition parties are given at the end of each month for 1+ years of service at OUR CLIENTQuest for the Best! Employee Referral ProgramAll regular full-time and part-time employees are eligible to refer individuals for the program. The referring employee may receive from $1,500 to $3,500 depending on the position and the difficulty in filling the position.

On-Site ServicesOUR CLIENT helps you save time and money by offering several convenient on-site services, which include dry cleaning, film developing, shoe and eyeglass repair, and hot lunches.

Wellness ProgramReimburses employees up to $300 per calendar year towards qualifying health club memberships and or weight loss programs.

Employee Assistance ProgramCounselors are available 24 hours a day, 365 days a year to provide information on a wide range of topics/issues including referral services, legal, financial, parenting issues, personal and work-related problems.

Shuttle ServicesOUR CLIENT offers free commuter shuttles that conveniently pick up at the Bart and CalTrain station and drop you off at the office.

CitiBank at Work ProgramAll employees and members of their families or households are eligible to join.

Flu ShotsOn-site flu shots are offered annually.

Softball TeamOUR CLIENT encourages having fun and teamwork by giving employees the opportunity to be a part of the wonderful Brisbane Stars softball team.

To review our credentials and accolades please go to our website: www.clinicalbrokers.com

Ask our clinicalBROKERS Occupational Consultants about our Referral Bonus ProgramJob type: Full TimeEducation: BachelorExperience: 3-5 Years


To Apply:
Sign up and submit your resume on Jobirn.