Pharmacovigilance/Drug Safety Data Entry Officer Hiring at ProductLife Group
- Pharmacovigilance/Drug Safety Data Entry Officer Hiring at ProductLife Group
- Join ProductLife Group as a Pharmacovigilance/Drug Safety Data Entry Officer
- Job Overview
- About the job
- Key Responsibilities
- How to Apply
Pharmacovigilance/Drug Safety Data Entry Officer Hiring at ProductLife Group
Join ProductLife Group as a Pharmacovigilance/Drug Safety Data Entry Officer
Are you passionate about drug safety and regulatory compliance? ProductLife Group (PLG) is looking for a Pharmacovigilance/Drug Safety Data Entry Officer to join our team. If you have expertise in adverse event reporting, safety database management, and regulatory compliance, this role could be a great fit for you!
Job Overview
- Position: Pharmacovigilance/Drug Safety Data Entry Officer
- Company: ProductLife Group (PLG)
- Employment Type: Full-time
- Education: PharmD, BSc/MSc in Life Sciences, Pharmacy, or a related field
About the job
ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.
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Key Responsibilities
As a Pharmacovigilance/Drug Safety Data Entry Officer, you will be responsible for:
Responsibilities
- To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required
- Management of the generic or client specific email boxes as appropriate.
- Registration, triage, assignment and coordination for the processing of vigilance cases
- Follow-up requests with local reporters
- Responding to queries from client and reporters
- To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
- Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed
- To participate in audits / inspections and resulting action plan
Education And Experience
- Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
- 2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
- Previous experience working to deadlines.
- Client communications
- Knowledge of US and EU PV regulations
- Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
Skills
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Excellent time management skills
- Accountability and autonomy with assigned tasks
- Process orientated with good attention to detail
- Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
- Flexibility and adaptability to handle a dynamic workload
- Works well under pressure and working to timelines
- Safety database experience
How to Apply
If you meet the qualifications and are passionate about drug safety, we encourage you to apply today!
Apply via LinkedIn
To apply for this job please visit www.linkedin.com.