Imagine a company which the allure of innovation meets excellence, skill fuses with services, and perfection blends with production. GAP is a robust, nimble, and state-of-the-art provider of bio-pharmaceutical Contract Development Manufacturing, Research, Business Processing Organization, and Strategic Consulting group We are a bricks and Mortar company. We employ 1682 Full Time Employees in 49 countries with offices in N. American, Latin America, Common Wealth of Russia as well as India. In short, we empower our clients both locally and globally
Post: Manager Pharmacovigilance
Job Description:
- To attend all relevant study meetings and management meetings
- To help Pharmacovigilance staff comply with regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees and Investigators
- To participate in training sessions and workshops
- To represent the Pharmacovigilance department within the company
General Duties:
- Assist in the development of processes and preparation of SOPs
- Assign responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business
- Support Business Development efforts with new and revised projects. Interact independently with Sponsors not directly involved in their projects and to assist in wider departmental tasks. Represent the department at face to face meetings.
- Oversee development of efficient processes for the intake and triage of safety reports
- Ensure compliance metrics are maintained for the team
- Ensure that they, and/ or their respective teams, provide the counsel and subject matter expertise to other departments
- Perform other duties as required by the Department
- Ability to maintain confidentiality of data and information during interactions with staff at all levels
- Extensive experience in Pharmaceutical or CRO industry, including line management
- Extensive knowledge of global pharmacovigilance/drug safety for clinical trials and licensed products
- Demonstrated ability to conduct pharmacovigilance activities effectively, efficiently and with the minimum of supervision
- Full understanding of the principles of ICH GCP and regulatory requirements
Candidate Profile
Minimum 2 to 3 years of experience managing a team, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Bachelor’s degree in Life Sciences or related discipline
Post-graduate degree in Life Sciences preferred
Good computer literacy with working knowledge of Windows and Microsoft Office applications
Good oral and written communication, organizational skills and personal presentation.
The ability to communicate effectively in English
Additional Information:
Experience: 5 to 7 years
Qualification: Life Science/Health science
Location: Chennai
Functional Area: Pharmacovigilance
Industry Type: Pharma
Employment Type: Full Time
Salary: Industrial standards
End Date: 10th June, 2016
APPLY
Interested candidates may forward their Resumes to hr_rec@gapsos.com
Phone: 044 64521706
Posted by,
NIVEETHA S,
Global Allied Pharmaceuticals
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