PrimeVigilance
Location
Pune | India
Job description
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
The Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS).
• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.
• To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical
understanding and evaluation of any safety issues
• To review and provide input in periodic reports
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal
Product or other safety related findings
• Reviewing database outputs
• Can be delegated to support signal detection activities upon acquiring sufficient experience
• Proposing a course of action whenever a new risk is identified
The PV Physician should be medically qualified as a physician with demonstrated experience in PharmacoVigilance and working in a clinical setting.
Excellent interpersonal skills
Ability to plan, organise, prioritise and execute multiple tasks
Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
Communication skills
Presentation skills
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!
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