Pharmacovigilance Services Specialist
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
Chennai
Énoncé sur l’égalité d’accès à l’emploi, Demandes d’accommodement et Autres énoncés en matière d’emploi
Notre engagement envers l’inclusion et la diversité
Chez Accenture, l’inclusion et la diversité sont essentielles à notre culture et font partie intégrante de nos valeurs fondamentales. Nous sommes engagés à créer un environnement où nos employés sont à l’aise, sont eux-mêmes et contribuent. À l’image du Canada, le personnel d’Accenture est composé d’une très grande variété de cultures, d’origines ethniques, de croyances, d’expériences et de langues. Nous offrons un environnement inclusif, sans égard aux caractéristiques personnelles comme l’origine ethnique, la religion, le genre, l’orientation sexuelle, l’identité ou l’expression du genre, l’âge ou le handicap.
Demandes d’accommodement
Accenture s’engage à offrir l’égalité d’accès à l’emploi aux personnes handicapées ou pratiquant une religion, notamment en offrant les accommodements raisonnables nécessaires. Si vous êtes embauché par Accenture et que vous avez besoin d’accommodements pour remplir les fonctions essentielles de votre rôle, vous serez invité à participer à notre processus d’accommodement raisonnable. Les accommodements consentis pour faciliter le processus de recrutement ne sont pas une garantie d’accommodements futurs ou continus après l’embauche.
Si vous souhaitez être pris en considération pour un emploi chez Accenture, et que vous avez besoin d’accommodements pour un handicap ou une pratique religieuse, veuillez nous appeler sans frais au 1-877-889‑9009, envoyez-nous un courriel ou communiquez avec le service de recrutement.
Autres énoncés en matière d’emploi
Nous avons pour objectif d’offrir à notre personnel des postes à proximité de leur lieu de résidence. Cependant, étant donné la nature de nos activités et nos obligations envers nos clients, nos employés doivent être prêts à voyager au besoin.
Les candidats à un emploi ne sont pas tenus de divulguer les infractions pour lesquelles une grâce a été accordée.
Afin de vous offrir le processus de recrutement le plus efficace, Accenture peut utiliser l'intelligence artificielle pour déterminer la correspondance entre votre candidature et les exigences du poste auquel vous avez postulé. La décision définitive sera toujours prise par l’équipe de recrutement après avoir examiné l’intégralité de votre profil de candidat(e). Durant le processus de soumission de candidature, vous pouvez choisir de ne pas participer à ce processus de sélection par intelligence artificielle et être assuré(e) que cela n’aura pas d’impact négatif sur votre perspective d’emploi chez Accenture.
We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.
We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.
At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.
Join Accenture to work at the heart of change. Visit us at www.accenture.com.