The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations.
About You - Education, Experience, Skills
- Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
- Fresher / Upto 2 years of experience reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience (i.e., an information science degree with at least 1 year of relevant working knowledge of supporting drug and patient safety)
- Strong analytic ability to analyse and summarize the main points of biomedical case reports, studies, or specific topics.
- Working knowledge of biomedical terminology, drugs, and therapeutic areas.
- Experience with commercial and client-specific biomedical literature databases.
It would be great if you also had . . .
- Effective time management skills
- Excellent English written and verbal communication skills
- High motivation with a strong work ethic and ability to thrive in a fast-paced workplace
- Adherence to SOP and Policies
What will you be doing in this role?
- Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures.
- Write brief narratives summarizing the ICSR criteria and other potentiall