PrimeVigilance hiring Pharmacovigilance Associate pune

PrimeVigilance hiring Pharmacovigilance Associate pune
  • Full Time
  • pune
  • 30000 USD / Year
  • Applications have closed

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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Vacancy Details

  • 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.
PrimeVigilance hiring Pharmacovigilance Associate pune
PrimeVigilance hiring Pharmacovigilance Associate pune

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.



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