Life Science Vertical Head

Life science Vertical Head/Exp 10-20 years/Locations - Hyderabad

Our client is one of the most experienced and fastest growing Clinical Research Organization incorporated in September 2004.Their facilities are accredited by DCGI (Drugs Controller General,India), NABL (National
Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA and France AFSSAPS and conforms to ICH and CDSCO-GCP & GLP Guidelines.

Designation:Life Sciences Head

Location:Hyderabad

Qualification & Expertise Required:

Medical (MBBS / MD) / Life sciences / Pharmacy background with 10-15 Years experience in Clinical Research, Pharmacovigilance & Clinical Data Management.

Essential Function:

- Provide overall management of Operations / Studies.

- General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone
planning and tracking, ensuring that projects are progressing according to contract and quality standards, management of communication between the company¡¦s project team, Sponsor, contract and financial management and liasoning with regulatory authorities.

Responsibilities:

- Initiation/Planning/Implementation/Control & Evaluation of PV / Data Management:

- Manage and oversee the operations wrt to PV & CDM

- Responsible for preparation and/or review of relevant standard operating procedures as per the current technicalities with respect to industry practices.

- Ensure proper SOP and technical /professional trainings as well as actively involved in mentoring of staff and hiring the relevant staff with required qualification and expertise as and when the requirement arises as
per the budget of the department .

- Planning & execution of projects as per all applicable regulatory requirements and as per the approved quality system procedures and standard operating procedures.

- Manage and lead a group of Therapeutic Area Teams and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures.

- Responsible for overall workload management and resource allocation within the group.

- Responsible for overall quality management of the group and implement quality improvement initiatives as appropriate.

- Work closely to set departmental strategy and achieve group objectives.

- Lead,support and setup of overall projects related to Pharmacovigilance & data management till successful delivery.

- Responsible for setting up the schedule of periodic safety regulatory reports and annual product reviews & ensure quality and timely preparation & release of assigned PSURs as appropriate. QC of periodic regulatory
safety reports before submission to management approval.

- Set up yearly objectives and review performances of the team ensuring best use of available resources. Discuss and set up development plans for all team members to further develop individual¡¦s skills and potentials.

- Responsible for overall training strategy. Support the training of other departments in clinical safety related procedures/regulatory obligations.

- Work with external partner groups, eg co-licensing partners to meet joint accountabilities

- Represent the pharmacovigilance team at internal and external meetings

- Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.

- Ensure Number, timeliness and quality of deliverables according to established directives.

- Recruitment, retention and development of talent in the team and accurate allocation and efficient usage of available resources within the team.

- Promote innovation to improve processes and deliverable quality.

- To ensure readiness of the depts and all study/system related documents for the audit process (QA audit, any regulatory/Sponsor audit etc) at all times.

- Preparing study documents and assisting the Quality assurance unit during regulatory authorities¡¦ inspections / audits.

- Responsible for all the sponsor audits as per the applicable regulations and internal standard operating procedures.

Sponsor / External Liaison:

- To liaise well with external sponsors and internal team and other departments towards Business Deliverables and work closely with other departments and higher management towards ensuring business interests.

Communication:

- Communicate with Business Development team regarding projects related to Pharmacovigilance & data management and taking the onus in communicating study related updates to the sponsor and EC during or after the study completion.

- Responsible for all communications with regulatory body.

Skills:

- Excellent interpersonal, site management and relationship building, verbal and written communication skills including excellent presentation skills at conferences, meetings, training sessions

- Demonstrated ability to manage and motivate direct reports Team player with outstanding negotiation and organizational skills Client focused approach to work

- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

- IT literate (experience with Microsoft based applications and general knowledge of PC functions)

- Able to take initiative and work independently

- Sense of urgency in completing assigned tasks.

Do send your profile with - Designation, Skillset, Yrs Of Experience & location - mentioned in the subject line.

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