MAIN PURPOSE OF JOB

Provide support for safety evaluation and risk management activities of products in clinical development and post marketing.

KEY RESPONSIBILITIES

•Oversees the documentation of serious adverse events (SAEs) reported in clinical trials

•Interacts with Pharmacovigilance CROs when needed to maintain documentation of SAE data

•Coordinates internal meetings such as, but not limited to the Safety Review Team (SRT) Meetings and Medical Review/PV Meetings

•Provides AE/SAE listings as needed for ongoing pharmacovigilance activities and analyses

•Assist with data reconciliation and retrospective safety database review.

•Supports Clinical Operations Team by providing data and pharmacovigilance expertise as needed

•Supports the safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts

•Ongoing oversight of PV Vendor to support case quality and compliance.

•Monitors Safety inbox

•Reviews/approves vendor Safety Management Plans

•Maintains cross-functional safety distribution list

•Maintains tracker of vendor personnel for training; Assists with quality review of training materials.

•Assists with SOP and Work Instruction creation and update.

Experience & knowledge & Education

•Targeting 2 years in Pharmacovigilance, preferably in the pharmaceutical or biotech industry, with case processing experience.

•Bachelors degree in biomedical or health care related specialty (RN/BSN preferred)

•Strong knowledge of clinical development process

•Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality

•Expert evaluation skills and analytical thinking

Desirable

•Knowledge of drug approval process in major countries

•Knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial and post-marketing reports.

ESSENTIAL COMPETENCIES

1.Communication Proficiency.

2.Must work with professional discretion and confidentiality

3.High Prioritization

4.Self-motivated- able to work autonomously

5.Able to anticipate challenges and devise strategies for success

6.Result and deadline orientated

7.Time Management.

8.Collaboration Skills, and ability to work as part of a diverse team

Pay and Benefits

The pay range for this position is $35.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 26, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $35 - $60