Senior PV Associate

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 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, company protocols, and client-specific requirements.

• Conduct ICSR follow-ups, manage SAE/SUSAR, including unblinding, clinical trial reconciliation, and protocol assessments.

• Evaluate Safety Management Plans.

• Execute clinical and partner reconciliation tasks.

• Oversee personal data protection activities.

• Address Product Quality Complaints and collaborate with Quality Assurance.

• Liaise with Medical Information teams.

• Conduct MedDRA and WHO coding.

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

• Assist in workflow and resource management.

• Support pharmacovigilance processes associated with ICSR management for PrimeVigilance and its clients.

• Undertake responsibilities assigned to junior positions under SOPs when applicable.

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

• Act as LCPPV for the designated country and PRLS for the specified language, as agreed upon with the line manager.

⛳️ Requirements

• Degree in life sciences, pharmacy, nursing, or other healthcare-related qualifications or experience in pharmacovigilance.

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

• Strong organizational skills, with a focus on attention to detail and the ability to multitask.

• Management capabilities, including time and issue management.

• Proficiency in English, both spoken and written, at an advanced level.

• High level of competency in MS Office applications.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional development.

• A friendly and supportive working atmosphere.

• Chance to collaborate with colleagues from around the globe, with English as the primary language of communication.

• Commitment to providing equal opportunities in the workplace.

• A human-centric work environment.

• Support for employee experience, well-being, and mental health.

• Excellent training and development resources.

• Promotion of a healthy work-life balance.