PV Associate

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Assist with various activities carried out by the project team on behalf of both the client and the company.

• Execute ICSR management tasks within the established scope and timelines.

• Process Individual Case Safety Reports from all sources while adhering to relevant regulations, PrimeVigilance procedures, client requirements, and deadlines.

• Conduct follow-up activities related to ICSR.

• Oversee Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan evaluation.

• Carry out clinical and partner reconciliation.

• Manage personal data protection tasks.

• Address Product Quality Complaints and collaborate with Quality Assurance.

• Engage with Medical Information.

• Execute MedDRA and WHO coding.

• Assist in pharmacovigilance processes pertaining to ICSR management for PrimeVigilance and its clients.

• Provide support to the RA & PV Network Department as required.

• Serve as LCPPV for the specified country upon agreement with the line manager.

• Function as PRLS for the designated language when agreed upon with the line manager.

⛳️ Requirements

• Graduate in life sciences, pharmacy, nursing, or another healthcare-related field, or possess experience in pharmacovigilance.

• 0-1 year of experience in pharmacovigilance is preferred but not mandatory.

• Strong organizational skills, including attention to detail and the ability to multitask.

• Effective management skills, encompassing time and issue management.

• Proficient spoken and written English.

• Advanced proficiency in MS Office applications.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth and professional development.

• Collaborative and supportive team culture.

• An inclusive workplace that fosters a sense of belonging.

• Chance to contribute to patient safety and pharmaceutical treatment.

• Global collaboration across Europe, North America, South America, Asia, and Australia.