Drug Safety Manager

Pharmacovigilance Manager

Description:

• Medical review of ICSRs.

• MedDRA coding

• Expectedness assessment.

• Causality Assessment and Company Comment.

• MedWatch and CIOMS review.

• Overview of compliance in relation to the quality, completeness and timeliness of ICSRs.

• Aggregate reports

• Preparation of yearly schedule of periodic reports.

• Ensure that all pharmacovigilance documents are prepared in time and are quality controlled.

• Overview of compliance in relation to the quality, completeness and timeliness of aggregate reports.

• Signal Detection activities

Required Experience

• Bachelor's degree or equivalent in Human Medicine or Pharmacy.
• A minimum of 3 year's experience in similar position or a minimum experience of 6 years in pharmaceutical industry/CRO

Required Skills

o English language: advance level (both speaking and writing, good understanding of medical

English terms is a must).

o Computer skills: very good knowledge of MS Office tools (MS Excel knowledge is a must).

Experience Level:

Expert Level

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.