Job Description
Position: Pharmacovigilance Services Specialist
Skill Required: Pharmacovigilance & Drug Safety Surveillance
Qualifications: Any Graduation
Experience: 8 to 9 years
About Accenture
Accenture is a global professional services company with expertise in digital, cloud, and security. With unmatched experience across more than 40 industries, we provide Strategy and Consulting, Technology and Operations services, and Accenture Song—empowered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our team of 699,000 professionals delivers on the promise of technology and human ingenuity daily, serving clients in over 120 countries. We embrace change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.
Role Overview
As a member of our Life Sciences R&D vertical, you will play a vital role in supporting biopharma companies by managing drug safety and regulatory services. This position involves overseeing case management, including identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in compliance with client guidelines and global regulatory requirements.
Key Responsibilities
Prepare and review Periodic Safety Update Reports (PSURs) according to client Standard Operating Procedures (SOPs) and Work Instructions.
Identify contributors for PSUR preparation and coordinate kick-off meetings (KOM) with relevant stakeholders.
Liaise with Client Drug Regulatory Affairs to gather necessary information such as brand names and registration procedures.
Collaborate with the Client Pharmacovigilance Data Management team to confirm drug codes.
Ensure the accuracy of data and timely processing of relevant cases in accordance with PSUR schedules.
Lead the preparation of submission-ready draft reports and perform peer reviews, providing constructive feedback.
Maintain documentation and archival of all PSUR-related information, ensuring completeness and accuracy.
Coordinate with Novartis stakeholders for quality control and regulatory review.
Escalate any delayed inputs promptly and manage the PSUR Mailbox for publication processes.
Qualifications
Educational Requirements: B.Pharm / M.Pharm / PhD / BDS / BHMS / BAMS / Master's in Life Sciences.
Experience: 4 to 5 years in drug safety or related fields; 2 years in medical writing or aggregate report preparation is a plus.
What We’re Looking For
Strong analytical and problem-solving skills with attention to detail.
Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.
Familiarity with pharmacovigilance regulations and best practices.
Ability to work independently and manage multiple tasks in a fast-paced environment.
Join Accenture and be a part of a team that drives innovation and success in drug safety and patient care!
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
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Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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Remote - Europe | Remote - Middle East | Remote | Switzerland | Remote, USA |Bucharest :
Bucharest |Makkah :
Najran | Rabigh | Riyadh | King Abdullah Economic City | Jeddah | Khulais |Nišava District :
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