Job Description
Skill required: Pharmacovigilance Operations – Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications: Bachelor of Pharmacy/Master of Pharmacy/Master Of Physiotherapy
Years of Experience: 7 to 11 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com
What would you do? The pharmacovigilance medical review associate conducts medical review and assessment of adverse event cases reported for marketed pharmaceutical products under the direction of the medical review team lead. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? Doctor of Medicine or MBBS Medicine degree – 2+ years of experience in pharmacovigilance and adverse event medical review – Working knowledge of regulations governing drug safety and pharmacovigilance – Proficiency in standard causality assessment methodology – Attention to detail with strong data analysis capabilities – Excellent written and verbal communication abilities – Strong analytical thinking and problem-solving skills – Ability to work independently as well as collaboratively on a team
Roles and Responsibilities: Review and analyze adverse event data associated with pharmaceutical products to evaluate potential risk signals – Critically assess adverse event case reports to determine causality in relation to marketed products – Identify unusual adverse events or increases in event frequency that may qualify as reportable safety signals – Categorize and codify adverse events using standard medical terminology for aggregation and trend analysis – Prepare adverse event case summaries and analysis for inclusion in periodic safety reports and regulatory documentation – Enter adverse event data into appropriate pharmacovigilance tracking and reporting databases – Maintain current knowledge of regulations, guidelines, and standards for pharmacovigilance activities – Follow documented procedures for adverse event intake, review, analysis and reporting – Participate in medical review team meetings to discuss findings and recommendations