Senior Specialist Clinical Safety Lisboa

Senior Specialist Clinical Safety
Lisboa
Lisboa, Lisboa, Portugal

Job Details

We have an exciting opportunity for a Senior Clinical Safety Specialist to join our team in Spain!

The role will include:

1. Management of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) process: receipt, data entry, narrative writing, request follow up, request medical assessment and expedited or aggregate reporting.
2. Data entry (and Quality Control of simple cases) of adverse event reports in databases such as ABCube Safety-Easy, Argus.
3. Med
   DRA coding of Adverse Events.
4. Reporting of reports that fulfill the criteria for expedited reporting either via validated E2B compliant safety database or through the EVWEB, the EMA reporting tool for ICSRs and SUSARs.
5. Reconciliation between the SAEs and the clinical study database.
6. Support the Clinical Safety Lead with the design and development of Safety Management Plan for clinical trials.
7. Writing and submission of Development Safety Update Reports (DSUR) under supervision.
8. Review the legislation for Pharmacovigilance Regulatory Intelligence (PV-RI) in clinical trials purposes.
9. Support in preparation of internal and external audits/inspections and delivering requests.

The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point, and additional reasonable tasks that align with their abilities, qualification, and training, if required.

Skills

• Team-oriented approach
• Organizational skills, ability to
  - task. Ability to assimilate and analyse information rapidly.
• High sense of responsibility and
  - motivation
• Highly
  - oriented
• Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
• Fluent written and spoken English skills.
• Excellent written and verbal communication skills.

Experience/Background

• Successful completion of a Bachelor’s degree in medical, natural sciences or
  - related field or Degree in Medicine
• At least 1 year of relevant professional experience in the field of Pharmacovigilance.
• Knowledge of safety databases (Argus, Safety Easy are preferred)
• Experience in case management activities
• Previous experience in
  - authorisation area.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Affiliated Companies: Pharma
Lex Spain S. L. U.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are
- discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888. 692. 2272 or email hrsc@cencora.com. We will make accommodation determinations on a
-
- request basis. Messages and emails regarding anything other than accommodations requests will not be returned.