Skip to main content

Opportunity to join PPD Pharmaceuticals as Scientist (Level II)

 

Clinical courses

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.

Post: Scientist (Level II) - Bangalore-122132

Job Description:
To plan, co-ordinate and deliver, under supervision, components of the signal-detection services contracted to PPD.

To use PPD or client procedures (and other departmental tools or systems as required), current regulations and ICH/local guidelines regarding signal detection/safety surveillance, and scientific/clinical expert knowledge in order to establish and execute high-quality signal-detection activities in line with Client-specific and departmental objectives.


To participate in the development of new signal detection systems and processes as required.

Performs under supervision routine signal-detection/safety-surveillance activities, and drafts signal evaluation reports as directed by senior signal-detection staff, the Safety Review Team (SRT) lead and/or the safety physician
- Effectively collaborates with client and PPD’s internal matrices to produce high-quality deliverables, ensuring that safety information and findings are proactively and timely identified, analyzed and disseminated
- Promptly communicates, and escalates new safety-related observations, as appropriate, with safety physician and/or SRT lead in order to fulfill deliverables
- Supports the preparation of updates to Core Safety Information and associated supporting documentation, as directed by the SRT lead or safety/product physician, relevant SRT representatives or Senior signal-detection Staff for safety-based labeling updates or Marketing Authorization support as needed
- Tracks signal-detection activities and metrics, and generates reports for compliance-review by senior signal detection staff as needed.
- Supports client/project matrix interactions including preparation of service-kick-off materials
- Supports signal-detection planning activities during service initiations
- Obtains product-specific historical  and existing safety documentation as directed by senior signal-detection staff and reviews these to draft Signal-Detection and Management Plans
- Carries out administrative Business activities including attending team calls or meetings as required, timely submits project billing and expense reports, and arranges business travel for self in collaboration with PPD Travel when required.
- Maintains up-to-date training records.
- Routinely ensures their scientific, regulatory and process knowledge is up to date, and attends planned Training sessions and reviews.
- Supports Senior signal-detection staff with business development activities
- Attends audit or bid defense meeting


Minimum Required Education and Experience Preferences:
Requirements:
- Bachelor's degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience
- Or Life Science degree with 2+ years of relevant industrial or clinical experience and 2+ years of pharmacovigilance experience
- Clear and detailed writing skills and analytical thinking for scientific literature review, pertinent data gathering, data synthesis, analysis and authoring aggregated data summaries
- Job holder should be able to apply company policy and procedure to resolve variety of issues whilst developing professional expertise

Preferences
- 3 years of pharmacovigilance
- Post-approval pharmacovigilance experience
- Experience of compilation and review of safety data and/or integration of safety data, including use of coding dictionaries
- Experience and understanding of proactive safety-management tools systems and mechanisms strategies
- Good knowledge of relevant pharmacovigilance regulations and applicable methodologies for data-analysis activities
- Good understanding of the drug-development drug-approval process within the ICH regions

Required Knowledge, Skills and Abilities:
- Sound computing skills
- Basic knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug-utilization and safety at the population level
- Knowledge of medical and drug terminology, including coding dictionaries
- Skills to manage and co-ordinate tasks and projects with competing priorities
- Ability to work to a regulatory deadline
- Highly effective communication skills and use of English language
- Effective negotiating skills

Additional Information:
Experience:
2+ Years
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Job Code: 122132
End Date: 15th May, 2015

APPLY THROUGH RECRUITERS PORTAL>>

See All   B.Pharm Alerts   B.Sc Alerts   Mumbai Alerts

See All   Other Jobs in our Database

PharmaTutor Magazine- Latest Issues

Subscribe to Pharmatutor Job Alerts by Email