Offer summary

Qualifications:

Bachelor's degree in Life Sciences is required., Minimum of 5 years of relevant experience, including 3 years in Pharmacovigilance., Strong understanding of global and local pharmacovigilance regulations and guidelines., Excellent written and verbal communication skills, with proficiency in English..

Key responsabilities:

Lead and oversee local pharmacovigilance activities to ensure compliance with regulations.

Monitor safety-related operations and serve as the primary contact for the Sponsor.

Create and manage Individual Case Safety Reports (ICSR) and follow up with reporters as needed.

Collaborate with internal and external stakeholders to support quality assurance and audit readiness.

Job description

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: Bachelor's degree in Life Sciences

• Experience:

Minimum 5 years of relevant experience.
Minimum 3 years of Pharmacovigilance experience.

• Skills:

Strong understanding of global and local pharmacovigilance regulations and guidelines.
Excellent written and verbal communication skills.
Proficiency in English.
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

100% home-based role

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Required profile