Senior PV Associate

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

📋 Description

• Provide support for various activities conducted by the project team on behalf of both the client and the company.

• Execute ICSR management tasks within the defined scope and deadlines.

• Process Individual Case Safety Reports from all sources, adhering to relevant regulations, company procedures, client requirements, and timelines.

• Conduct follow-up activities related to ICSR.

• Manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including unblinding, clinical trial reconciliation, and protocol review.

• Review Safety Management Plans.

• Perform clinical and partner reconciliations.

• Oversee personal data protection activities.

• Address Product Quality Complaints and collaborate with Quality Assurance.

• Interact with Medical Information services.

• Execute MedDRA and WHO coding.

• Generate database outputs and reports, including monthly client reporting data.

• Assist in workflow and resource management.

• Support pharmacovigilance processes related to ICSR management for PrimeVigilance and its clients.

• Provide assistance to the RA & PV Network Department as necessary.

• Serve as LCPPV for the designated country when appointed.

• Act as PRLS for the assigned language when designated.

⛳️ Requirements

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

• At least 1 year of experience in the field of pharmacovigilance.

• Strong organizational skills, with a keen eye for detail and the ability to multitask effectively.

• Management capabilities, including time management and issue resolution skills.

• Proficient in English, both spoken and written.

• Advanced proficiency in MS Office applications.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive working atmosphere.

• The chance to collaborate with colleagues from around the globe.

• English is the official language of the company.

• A workplace that promotes equal opportunities.

• A human-centric environment that values staff.

• Emphasis on employee experience, well-being, and mental health.

• Promotion of a healthy work-life balance.