Senior Specialist, Pharmacovigilance

• Performing triage and review for initial validity assessment of cases including spontaneous, health authority, clinical trial and literature cases.

• Data entry into PV database.

• Initial ICSR assessment, if applicable.

• Evaluation of the need for expedited reporting to health authorities / partners of a client concerned, including reporting timelines.

• Preparation of standard reporting forms (eg, CIOMS I / MedWatch Forms and XML .

• Preparation and sending of follow up requests.

• Submission of ICSRs to health authorities and partners of a client.

• Conduct quality checks of Individual Case Safety Reports (ICSRs) and ensure quality assurance in accordance with project requirements, maintaining compliance with industry standards and best practices to enhance the integrity and reliability of safety data.

• The ICSR search/retrieval process from the EVWEB database and company/noncompany assessment for cases.

• Allocation and cases workload management.

• Providing training in the system to the respective team members.

• Actively mentoring and supporting new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development.

• Responsibilities will be assigned by the supervisor in accordance with process requirements.

• 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, qualifications and training, if required.

Qualification:

• Professional education or University degree in Life Science

Experience:

• Minimum 1 year of experience in the field of pharmacovigilance.

Skills:

• Ability to prioritize and manage own time and tasks.

• Good communication skills (written and verbally)