PrimeVigilance hiring Pharmacovigilance Associate pune
career opportunity with PrimeVigilance in Pune as a Pharmacovigilance Associate. This job posting outlines the qualifications needed, job responsibilities, and the company’s values, offering insights into a rewarding career in pharmacovigilance.
About PrimeVigilance
PrimeVigilance, a division of Ergomed PLC, is a renowned pharmacovigilance service provider with a global presence. Established in 2008, we specialize in medical information, pharmacovigilance, regulatory affairs, and quality assurance, catering to pharmaceutical and biotechnology partners worldwide.
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- Position: Pharmacovigilance Associate
- Location: Pune (Hybrid work model)
- Experience: Fresher / 2-3 years in pharmacovigilance
- Department: ICSR Management
- Employment Type: Full-time, remote work available
Job Description
As a Pharmacovigilance Associate at PrimeVigilance, your responsibilities include:
Job Description
- Assures and exerts activities leading to effective cooperation with clients in the area of literature monitoring
- Contributes to achieving company´s goals and objectives
- Ensures that the Literature Screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) agreement.
- Works under supervision of more experienced colleague
- To assist with the development of literature search strategy
- To participate in weekly and ad hoc literature searches
- To participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated products
- To assist with ordering copies of full literature articles for review
- To maintain a record and track all literature abstracts screened and full literature article reviewed, with actions taken and the reason
- To forward any ICSRs to PV Associates for data entry into the global drug safety database
- File other relevant safety related information for use in signal detection and PSURs
- To participate in the screening of local non-indexed literature as required
- To assist in peer review QC of abstracts
- Accessing EV on daily basis and downloading MLM search and MLM ICSR results (excel spreadsheets)
- Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSRs
- Uploading the MLM search results and the list of ICSRs in the designated PrimeVigilance Portal area
- Reviewing the list of ICSRs daily
- Checking all urgent/immediate issues have been addressed in a timely manner;
- Keeping the EMA MLM Literature Screening Tracker up to date with the latest information received from the EMA
- Reporting to the unit head and more senior unit team members, and providing them with regular updates regarding project status and metrics concerning enquiries
- To assist with the development and improvement of literature screening processes and procedures
- Assisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits
Qualifications
Candidates should possess:
- Life science or biomedical background with a healthcare-related degree.
- Demonstrated experience in pharmacovigilance case processing.
- Previous experience in data entry or quality control.
- Proficiency in English (C1 level).
- Ability to work hybrid in Pune office.
Why PrimeVigilance?
At PrimeVigilance, we prioritize diversity, equity, and inclusion, fostering a human-centric work environment where everyone can contribute and grow. We offer:
- Training and career development opportunities.
- Emphasis on personal and professional growth.
- Supportive and friendly work environment.
- Collaboration with colleagues globally.
- Alignment with core values: Quality, Integrity, Drive, Agility, Belonging, and Collaboration.
Apply Now
Join PrimeVigilance in making a positive impact on patient lives. Apply now to be part of our dedicated team in Pune.