Location: Chandigarh

Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational human and veterinary products in accordance with the applicable regulatory requirements. Aggregate report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses.

Minimum qualification(s):
Master's degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in  Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) or Post-Graduation in Veterinary Sciences (M.V.Sc.); experience in the Pharmacovigilance industry would be an advantage. Good knowledge of medical terminology, fluency in written and spoken English, computer proficiency, an ability to work with web-based applications, and familiarity with the Windows 10/ Window 7 professional operating system and the MS Office suite (Word/Excel/Power Point), capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text, ability to evaluate data and draw conclusions independently, strong written and oral communications skills are required.

Location: Chandigarh

Report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Signal Evaluation Reports/ Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events; Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans (RMPs); Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues; Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs); Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives; Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs); Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions; Maintaining records in compliance with guidelines and SOPs.

Minimum qualification(s):
A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch; Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text; Ability to evaluate and interpret data, draw conclusions independently and synthesize scientific data; Fluency in written and spoken English; Proficiency in computer skills in Windows 10/ Windows 7 Operating system and the MS office suite (Word/Excel/Powerpoint) and an ability to work with web-based applications; Typing and transcription accuracy; Attention to detail.

Note::
Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position.