Work as Drug Safety Operations Lead at Bioclinica | M.Pharm, B.Pharm, Pharm.D
Post : Drug Safety Operations Lead
• Supervision and coordination of following activities:
• Lead and manage the project to comply with the SOW and SLAs.
• Supervise all project related activities.
• Single point of contact between the team and the client for smooth functioning of the project.
• Communicate between the management and the team.
• Record, maintain and track the metrics for both team members and project performance.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
• Process current incoming cases in order to meet timelines.
• Provide guidance for Data entry.
• Following up with sites regarding outstanding queries.
• Follow-up on reconciliation discrepancies.
• Follow departmental AE workflow procedures.
• Train and mentor new team members as per requirements of the project.
• Act as a management level liaison between Client and Bioclinica Project team
• Coordinate and manage administrative project issues
• Delegate tasks and responsibilities to appropriate personnel
• Identify and resolve issues and conflicts within the project team
• Recruit select and train team members
• Act as guide, coach and counselor for the team
• Following up with sites regarding outstanding queries and reconciliation of discrepancies
• Closure and deletion of cases
• Follow departmental AE workflow procedures
• Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates
• High level of proficiency at all workflow tasks
• Perform any other drug safety related activities as assigned
• Subject Matter Expertise in Safety database
• Proven experience in customer handling and relationship.
• Proven ability to perform task management.
• Proven People management skills.
• Must have good presentation skills and the ability to give presentations.
• Knowledge of the Life Sciences Industry a plus.
• Experience in entire drug development life cycle.
• Relevant product and industry knowledge
• Experience with relevant safety databases and software applications
• Any Healthcare professional (B pharm / M pharm / Pharm D or any other equivalent qualification)
• 5-6 years of experience in Pharmacovigilance
• Strong motivational skills and abilities, promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Ability to maintain professional and positive attitude
Experience : 5-6 years
Qualification : B.Pharm / M.Pharm / Pharm.D
Location : Mysore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Safety
End Date : 25th September, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube