Assoc Mgr, Safety Operations (with Portuguese Advanced)

Job Overview
The Assoc Manager Safety Operations Team is responsible for leading and overseeing all local pharmacovigilance activities ensuring compliance with regulations and best practices. This includes the implementation management and maintenance of the local pharmacovigilance system.

Key Responsibilities:
Oversight of Pharmacovigilance Operations:

• Monitor and oversee all safety-related operations and communication activities.

• Serve as the primary point of contact for the Sponsor (when applicable).

• Ensure efficient and accurate ICSR (Individual Case Safety Report) surveillance including collection reporting and follow-up.

• Manage translation processes as needed.

• Author local case narratives for regulatory reporting as required by local authorities.

Support & Collaboration:

• Support local literature searches reconciliations and quality assurance activities.

• Assist with audit and inspection readiness.

• Collaborate effectively with internal and external stakeholders.

Mailbox Screening:

• Monitor multiple regional/global AE email inboxes in various languages for all Customer Affiliates.

• Assess and take action on all received emails.

Case Intake:

• Create Case Reports into the Global Safety Database.

Follow-up Correspondence:

• Perform follow-up with ICSR reporters to obtain additional information as per SOPs.

Reconciliation:

• Conduct reconciliations with internal functions and licensing partners.

Compliance Investigations:

• Perform compliance investigations for specific cases.

Qualifications:

Education: Bachelors degree in Life Sciences

Languages: English and Portuguese advanced
Experience:

• Minimum 5 years of relevant experience.

• Minimum 3 years of specific Pharmacovigilance experience (intake case processing regulatory submissions)

Skills:

• Strong understanding of global and local pharmacovigilance regulations and guidelines.

• Excellent written and verbal communication skills.

• Proficiency in English C1/2 (mandatory). Will be evaluated.

• Proficiency in Portuguese C1/2 (mandatory). Will be evaluated.

• Strong organizational and time management skills.

• Ability to work independently and as part of a team.

• Proficiency in using electronic data management systems (e.g. Argus Apex).

Preferred Qualifications:

Experience working with global safety databases

Experience as people manager with direct reports
1 year Experience of Adverse Events Case Triage Processing and Submission.

100% home-based role

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