Job Type:
Full Time
Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding,
Company Description:
Name: PrimeVigilance (part of Ergomed PLC)
Established: 2008
Services Provided:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
Global Presence: Europe, North America, Asia
Client Base: Small to large pharmaceutical and biotechnology partners, including medical devices.
Employee Focus:
Investment in training and development.
Emphasis on employee experience, well-being, and mental health.
Promotes work-life balance for employee satisfaction.
Mission: Making a positive impact in patients' lives.
Job Description:
Position: Associate Safety Data Management Specialist
Responsibilities:
Processing Individual Case Safety Reports (post-marketing and clinical trials) in compliance with regulations and client requirements.
Conducting reconciliation activities for all received reports.
Working under supervision and mentorship.
Qualifications:
Life science or biomedical background.
Previous experience in Data Entry or Quality Control.
Demonstrated experience in Pharmacovigilance case processing (2-3 years).
ARGUS/Aris G experience preferred.
Strong time management, organization, and multitasking skills.
Excellent interpersonal and communication skills.
Ability to work in the Pune office on a hybrid basis.
Advanced English skills (at least C1 level).
Additional Information:
Why PrimeVigilance?
Equal opportunities workplace with a focus on diversity, equity, and inclusion.
Human-centric environment fostering personal and professional growth.
Training and career development opportunities.
Supportive working environment with colleagues worldwide.
