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2 Job openings at Apcer Life Sciences
Drug Safety Physician

Noida, Uttar Pradesh

0 years

INR 10.0 - 12.0 Lacs P.A.

On-site

Full Time

· Manage daily workload in conjunction with Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. · Medical review of ICSRs in APCER’s Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs. · Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. · Support in Signal detection of the ADRs with cases received from client's products (if applicable). · Medical Review of PSUR as per the Regulations and SOPs (if applicable). · Handling of medical query/spontaneous ADR cases as per applicable SOP (as applicable). · Trains and mentors new medical reviewers in PVG (if required) · Complies with applicable ISMS related procedures & policies · Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. · Generation and Execution of company standard operating procedures (SOPs) and Work instructions (WI). · Liaise effectively and maintain excellent relationship with the clients and internal/external contacts. · To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. · To carry out necessary administrative duties required for the job. · Builds and maintains good relationships across functional units and company affiliates. · Other duties as assigned by management. Job Type: Full-time Pay: ₹1,000,000.00 - ₹1,200,000.00 per year Application Question(s): Are you a MBBS/MD? Education: Bachelor's (Required) Work Location: In person

Drug Safety Physician

Noida

0 years

INR 10.0 - 12.0 Lacs P.A.

On-site

Full Time

· Manage daily workload in conjunction with Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. · Medical review of ICSRs in APCER’s Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs. · Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. · Support in Signal detection of the ADRs with cases received from client's products (if applicable). · Medical Review of PSUR as per the Regulations and SOPs (if applicable). · Handling of medical query/spontaneous ADR cases as per applicable SOP (as applicable). · Trains and mentors new medical reviewers in PVG (if required) · Complies with applicable ISMS related procedures & policies · Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. · Generation and Execution of company standard operating procedures (SOPs) and Work instructions (WI). · Liaise effectively and maintain excellent relationship with the clients and internal/external contacts. · To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. · To carry out necessary administrative duties required for the job. · Builds and maintains good relationships across functional units and company affiliates. · Other duties as assigned by management. Job Type: Full-time Pay: ₹1,000,000.00 - ₹1,200,000.00 per year Application Question(s): Are you a MBBS/MD? Education: Bachelor's (Required) Work Location: In person

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