Posted today · be early
Senior PV Officer
Ergomed
IndiaremotePosted today
Skill Required
Pharmacovigilance-OfficerDrug-Safety-SpecialistPV-SpecialistSafety-ScientistClinical-Safety-SpecialistPV-OfficerPhotovoltaic-Project-OfficerPV-CoordinatorSenior-PV-Design-EngineerPV-Operations-ManagerPV-Operations-SpecialistPV-Project-ManagerSenior-PV-System-Design-EngineerPV-Compliance-ManagerwrittenUnityandGoFulltime
Key highlights
- Level Required: 10-12 years of work experience in pharmacovigilance
- Notable requirement: Life science, pharmacy, nursing, or healthcare qualification
Role overview
At PrimeVigilance, a global pharmacovigilance specialist, patient safety is the core mission. The company helps clients navigate complex regulations from early development through post-marketing surveillance, focusing on processing and interpreting safety data to create actionable insights. Joining the Ergomed Group means working within a passionate, collaborative, and diverse team of experts in clinical research, pharmacovigilance, and quality consulting, operating in an environment built on kindness, flexibility, growth, and belonging across Europe, North America, South America, Asia, and Australia.
Responsibilities
- Providing support to other activities undertaken by the project team on behalf of the client and the company
- Performing activities in the scope of ICSR management unit within agreed extent and imeframe (including, but not limited to):
- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- Medical Information interaction
- MedDRA and WHO coding
- Database Outputs and Reports (including data for monthly reporting to clients)
- Workflow & resource management
- Mentoring and training of new and more junior employees within the department
- Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
- Supporting ICSR SMEs or contributing as one of ICSR SMEs
- More senior colleague may perform tasks assigned as per SOP to more junior position
- Performing activities in the scope of ICSR management unit within agreed extent and Timeframe
- Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
Requirements
- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- 10-12 years of work experience in pharmacovigilance
- Excellent communication (written and verbal) skills
- Organization skills, including attention to details and multitasking
- Delegation skills
- Planning and time management
- Technical skills
- Team working
- English – fluent (spoken, written
- Advanced literacy (MS Office)
Benefits
- An environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from
Additional details
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
- Originally posted on Himalayas
