Case Specialist

About the Role

ProductLife Group, a global consulting and outsourcing leader in the life sciences sector, integrates human expertise with intelligent automation to assist with the development and patient accessibility of therapies and health products. Supporting clients in biopharma, medtech, and consumer health, the firm manages an extensive global network. The Case Specialist role provides a key opportunity to join a specialized team focused on pharmacovigilance and drug safety, contributing directly to the management of therapeutic life cycles.

Requirements

• The ideal candidate will be a Doctor of Pharmacy or a trained Pharmacist with at least three years of experience in a similar role.
• You must possess a strong background in the pharmaceutical industry with a deep understanding of pharmacovigilance principles, adverse event reporting, and relevant regulatory requirements such as GVP, GCP, and FDA guidelines.
• Proficiency in database management and experience with causality assessment are essential.
• Candidates should also demonstrate strong communication skills, the ability to work effectively within a team, and a process-oriented approach.
• Flexibility, the capacity to multitask, and a track record of working successfully to strict deadlines are also required.

Responsibilities

• The Case Specialist is responsible for performing quality control on vigilance cases and conducting comprehensive medical evaluations of reports.
• Duties include entering vigilance data into appropriate databases, performing follow-up requests via phone and email, and pre-analyzing complex cases.
• You will evaluate coding according to established dictionaries, assess the causal relationship between products and effects, and determine the seriousness and status of reported incidents.
• Furthermore, you will validate documentation produced by other team members, identify submission requirements for individual cases, and analyze the inclusion or exclusion of specific case types.
• The role also involves performing quality control for clinical and post-marketing cases and acting as a primary point of contact for specific customers under the guidance of management.

Benefits & Perks

• This position offers the opportunity to work in a remote environment while engaging in purpose-driven work that makes a meaningful impact on global healthcare.
• You will collaborate with an innovative, forward-thinking global team and have access to various career growth opportunities.