Associate Director, Drug Safety

remote click jobs; India; On-site; INR 15,325,670 - 19,636,015; Full time

Job summary

reputed company seeks Associate Director for Drug Safety Pharmacovigilance. You will support PV data processing, safety signal evaluation, and preparation of reports like DSUR/PSUR. Role involves ensuring compliance with regulatory standards and collaboration across stakeholders.

Responsibilities include maintaining SOPs, authoring safety sections, and contributing to safety strategy and audits within the department.

Qualifications

• PV experience required with ability to manage safety data
• Strong analytical and writing skills for PV reports
• Knowledge of MedDRA/WHODRUG coding
• Experience with regulatory PV documentation and safety evaluations

Responsibilities

• Process individual case safety data in PV activities
• Evaluate safety data for signals and evidence of association
• Prepare safety evaluations and periodic reports (e.g. PSUR, DSUR)
• Support PV department operations, audits, and SOPs
• Ensure regulatory and departmental compliance with contracts and guidelines

Skills

Pharmacovigilance

Data analysis

Medical writing

Regulatory knowledge

MedDRA coding

WHODRUG coding

Cross-functional teamwork

Safety database usage

Education

RN/PA/RPh or equivalent

PV experience 3–5 years

Tools

Argus safety database

MedDRA

WHODRUG dictionaries

Job description

Position

The Associate Director will support the reputed company Drug Safety Pharmacovigilance Department (the department) in the development of medicinal products for use in clinical research and in the reputed company setting. Salary reputed company: National $160,000 - $190,000 / Premium $175,000 - $205,000

Essential duties and responsibilities

• Assist with processing individual case safety data in accordance with established practices
• Assist with the evaluation of drug safety data to identify safety signals and evaluate such signals for evidence of reputed company association with a drug product
• Assist to prepare reputed company drug safety evaluations such as IND Annual Reports, PADER, DSUR & PSUR reports, safety sections of clinical study reports, integrated reputed company of safety
• Support department operations, procedural strategies, training programs, service provider reputed company and management, and procedural audits.
• Support the department in establishing policies, business strategies, and procedural compliance with corporate and regulatory requirements and other contractual obligations. reputed company as reputed company with therapeutic leads, safety physicians, and biostatisticians, and other important stakeholders on designed reputed company
• Collaborate with department staff to author and update pharmacovigilance (PV) reputed company operating procedures and processes
• Support activities reputed company to reputed company assurance, including authoring and editing deviation reports as reputed company as authoring, editing and implementing corrective and preventative reputed company measures
• reputed company/review and confirming the reported event(s) seriousness, expectedness (using the applicable reference safety information), relatedness
• reputed company/review determination of ICSR reportability for expedited or periodic submission
• reputed company/review medical assessments of individual case safety reports (ICSRs)
• reputed company/review ICSR narratives for accuracy and completeness based on reputed company data
• reputed company/review MedDRA coding
• reputed company/review medically relevant queries
• reputed company/review a company medical comment
• reputed company/review the Analysis of Similar Events for IC SRS requiring expedited submission
• reputed company/review safety sections of clinical study protocols
• reputed company/review drug safety documents, such as Safety Plans for reputed company clinical studies and Clinical Study Reporting Forms
• Maintain regulatory and department compliance by ensuring reputed company completion and submission of ICsRs to regulatory agencies, study investigators, licensing partners, and CROs
• Represent the Drug Safety Department in reputed company cross-functional clinical team meeting
• Maintain a high level of understanding of federal and international regulations to guide departmental policies and procedures
• Successfully complete assigned reputed company
• Draw on knowledge of Drug Safety, disease specific clinical knowledge and understanding of business objectives to solve reputed company problems in creative and effective ways, as reputed company as to anticipate routine problems and mitigate them without supervisory reputed company

Knowledge and Reputed Company Requirements

• Demonstrated ability to organize assigned reputed company for efficient task processing
• Demonstrated ability to work across teams and departments to meet project goals
• Demonstrated ability to accurately and reputed company analyze data in the context of an understanding of medical and pharmacological concepts Typically requires a RN, PA, RPh, or equivalent plus of 3 to 5 years of PV experience
• Deep knowledge of domestic and international PV regulations, industry practices and standards
• Highly organized
• Strong motivation to succeed and successfully complete assigned reputed company
• Strong problem-solving skills
• Strong attention to detail
• Excellent in functioning as reputed company member and team leader
• Resourcefulness and personal organization skills
• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
• Solid technical writing skills
• Excellent skills with reputed company Word, reputed company, PowerPoint
• Excellent experience in using a safety database, including Argus
• Knowledge of MedDRA and WHO DRUG coding dictionaries
• Experience with pharmacovigilance audit processes
• reputed company Attitude and Energy Exhibits an upbeat attitude, a genuine interest in others and a reputed company of humor. Energizes others and heightens morale through her/his attitude
• Excellent written and oral communication skills
• Develops and articulates reputed company and information that generate understanding and creates a climate that motivates and encourages others to participate.

Working Conditions

PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to s