Skill required: Pharmacovigilance Services - Safety Writing
Designation: Pharmacovigilance Services Specialist
Qualifications:MBBS/MD
Years of Experience:3 to 8 years
Language - Ability:English(Domestic) - Expert
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 Services involve the detection, assessment, and prevention of adverse effects related to pharmaceutical products. These services ensure the safety and efficacy of medications by monitoring and analyzing data from clinical trials, healthcare providers, and patients. The goal is to identify potential risks and take appropriate actions to protect patient health. They also help pharmaceutical companies comply with regulatory requirements. Effective pharmacovigilance services are essential for maintaining public trust in medications. Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.
What are we looking for
- Minimum 3 years of experience in PBRER and RMP process Good knowledge on PBRER and RMP reports process Roles and Responsibilities:
- Participate in KOM, project planning/strategy making meeting.
- Ensuring the aggregate reports and RMP documents are medically relevant, complete, consistent and accurate.
- Providing inputs/insights from review of aggregated and RMP data aligned to client's processes(s) and SOPs.
- Addresses all previous Health authority comments and adhoc requests received from Health authority.
- Review and provide any noteworthy cases & published studies including pregnancy registries.
- Discuss and provide medical analysis for all relevant sections of AR and RMP
- To provide the conclusion regarding the current safety profile of the product.
- Address all medical queries/comments raised by the Client.
- Perform QC of all the assigned aggregate reports and RMP documents.
- Complete all trainings, assigned by internally or client on respective LMS within due date.
- Responsible for knowledge sharing, coaching, review and providing feedback of reports medically analyzed by the mentees.
- Notify critical and major deviations (referred, as Quality Issues) within one business days, and minor deviations within three business days to Accenture Quality Management team. Ensure to meet all SLAs and KPIs.
- Incorporate comments from Client (or external) stakeholders into the draft RMP/ associated documents and seek clarification where applicable.
