Full job description
Skill required: Pharmacovigilance – Medical Review
Designation: Deputy General Manager – Pharmacovigilance Services
Job Location: Bengaluru
Qualifications: MBBS
Years of Experience: 7 to 11 years
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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
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What would you do?
Responsible for medical review and assessment of Serious Adverse Events of Individual case safety reports within agreed timeframes and to a high standard of accuracy, in compliance standard operating procedures and global regulatory requirements. You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview. You will be expected to collect and perform a clinical review of medical records and related information to ensure that payment is made only for services that meet all Medicare coverage, coding, billing, and medical necessity requirements. Review and assessment of seriousness, causality, and labeling/expectedness of adverse events of individual case safety report in compliance with client standard operating procedures and global regulatory requirements.
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What are we looking for?
- Detail orientation
- Adaptable and flexible
- Agility for quick learning
- Ability to work well in a team
- Minimum of medical degree (MBBS). Medical degree with higher speciality preferred.
- A minimum of 2 years’ experience in a ICSR medical review.
- In-depth knowledge of medical terminology
- Good Communication Skills, medical writing skills and Analytical Ability
- Strong English Language proficiency
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Roles and Responsibilities
- Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labeling, causality and provide a medical assessment comment as needed for ICSR.
- Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary.
- Ensures all relevant information is in logical temporal sequence
- Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required.
- Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP.
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- Route the Case to Distribution and ensure the case is locked.
- Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases.
- Actively involved in case discussion with client and provide the valuable inputs to the team.
- Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness
- To participate in audits or inspections.
- Open to get trained and moved across roles based on business requirement.
- Training and mentoring of new associates.
- Authoring of process documents.
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