Pharmacovigilance Scientist

Manage processing, follow-up, analysis and regulatory reporting of AEs and SAEs for marketed and investigational human and veterinary products

Perform medical evaluation of safety cases in compliance with global regulatory requirements

Prepare aggregate safety reports including PBRERs, PSURs, Addendum PSURs, ACOs, PADERs and PSUR line listings

Perform quality checks of aggregate safety reports

Conduct signal detection related analyses including cumulative and issue-based event analyses

Ensure compliance with client conventions, SOPs and global pharmacovigilance guidelines

Maintain accuracy, consistency and timelines for all safety deliverables

Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics)

BDS / B.V.Sc. / M.V.Sc.

Pharmacovigilance industry experience preferred

Strong knowledge of medical terminology and pharmacovigilance processes

Excellent written and spoken English communication skills

Ability to prepare concise and accurate medical synopses and narratives

Ability to evaluate safety data independently and draw conclusions

Proficiency in MS Word, Excel, PowerPoint and web-based safety applications

Strong analytical and documentation skills

Continuum is a leading contract research organization providing services in Pharmacovigilance, Regulatory, Evidence Evaluation and Technology

The organization employs scientists and physicians to support global safety and regulatory operations