Pharmacovigilance Services Specialist

Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:Bachelor of Pharmacy/BSc. Nursing
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 784,000 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? 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. Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products. 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? •Educational and Experience Requirements: • MBBS (Medical degree) • Technology skills: experience with MS office, knowledge of safety database • Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred. • Good medical writing skills • Good Communication Skills • Strong English Language proficiency (Reading, Writing, Listening and Speaking). • Perform self-review for changes made to case during medical review and E2B validation check for all cases before routing to next workflow. • Respond to queries from internal teams, clients, license partners, regulatory authorities in a timely manner. • Contribute to maintenance and compliance oversight of PV processes and contribute to preparation and internal training on adverse events reporting. • Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents, reviewing safety case data and other pharmacovigilance documents for completeness and accuracy. • To perform assist and contribute in transition of related activities as per the client requirement. • To provide relevant approval as per SOP/SWI if needed. • Open to get trained and moved across roles based on business requirement. • Successfully complete and clear all applicable trainings within required timelines. Key performance indicators: • Ability to learn quickly and contribute to process improvement initiatives in consultation with management. • Consistent demonstration of company values/behaviors. • ICSRs are evaluated accurately and reviewed within the required timeframes to meet regulatory
Roles and Responsibilities: Responsibilities/Authorities • Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs). • Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP. • Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database. • Write company causality comment and route the case to applicable workflow as per Client SOPs • Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs • Lead the training of internal and cross-functional team members. • Actively involved in case discussion with client and provide the valuable inputs to the team. • Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates. • Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs • Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP. • Consult global safety physician for additional inputs on the case as required by client SOP. • Create action items in global safety database to ensure case details are sufficient for medical evaluation and route the case back for updating as per Client SOP • Please note that this role may require you to work in rotational shifts