Pharmacovigilance & Drug Safety
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Pharmacovigilance & Drug Safety Specialist Job @ PPD

BSc & MSc Life Sciences candidates can check out all of the details on a job vacancy that is available at PPD. Interested candidates with a Bachelor’s & Master’s degree in life sciences are eligible to apply online at PPD for the Associate Safety Specialist vacancy. Pharmacovigilance & Drug Safety. Check out all the information below:

Job Title: Associate Safety Specialist

Primary Location: Hyderabad, Telangana, India

Requisition ID: 161304

Job Description:

The Safety Specialist performs daily adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within an extremely regulated environment and driven by strict timelines. Pharmacovigilance activities include but aren’t limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.

Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, followup, tracking of reports, and regulatory reporting activities. Effectively collaborates with a variety of parties for example project team members, client contacts, investigators, and adverse event/ reporters, along with third-party vendors.

May help in the preparation of departmental and project-specific procedures and processes, prepare and to attend audits, kick-off and investigator meetings.

Minimum Required Education and Experience:

Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience OR Life Science degree with 2+ years of clinical experience and one year of pharmacovigilance experience Or equivalent combination of education, training, and experience that provides the individual with the necessary knowledge, skills, and abilities to successfully carry out the job.

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Required Knowledge, Skills and Abilities:

  • General understanding of pathophysiology and the disease process.
  • A detailed comprehension of relevant therapeutic areas as necessary for processing AEs.
  • Strong critical thinking and problem solving skillsGood oral and written communication skills such as paraphrasing skills.
  • Good command of English and ability to translate information into a local language where required.
  • Computer literate with the ability to work within multiple databases.
  • Previous exposures to Microsoft Office packages (including Outlook, Word, and Excel)
  • Understanding the importance of compliance with procedural documents and regulations.
  • Ability to manage and prioritize a variety of tasks and meet stringent deadlines with restricted supervision.
  • Strong focus on detail.
  • Ability to keep a positive and professional demeanour in challenging circumstancesAbility to work efficiently within a team to attain a shared goal.
  • Working Conditions.
  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both nationally and internationally.

Physical Demands:

  • Frequently stationary for 6-8 hours every day.
  • Repetitive hand movement of both hands together with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper neck and body.
  • Light to moderate lifting and carrying (or otherwise moves) objects such as luggage and laptop computer with a maximum lift of 15-20 pounds.
  • Ability to access and utilize many different computer software developed both off-the-shelf and in-house.
  • Ability to communicate ideas and information so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with other people to obtain or relate information to diverse groups. Works independently with little guidance or reliance on written or oral instructions and plans work schedules to fulfil aims.
  • Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability regarding the occurrence.
  • Ability to perform under stress.
  • Ability to multi-task.
  • Regular and consistent attendance.
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Working Conditions and Environment:

  • Work is performed in an office environment with exposure to electrical office equipment
  • Daily exposure to high pressure and intense concentration
  • Daily interactions with clients/associates Long, varied hours on occasion
  • Travel required on occasion domestic and/or international

Physical Requirements:

  • Frequently stationary for 6-8 hours a day Repetitive hand movement of both hands together with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists Frequent mobility required Occasional crouching, stooping, bending and twisting of upper body along with neckLight to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a max lift of 15-20 lbs.
  • Ability to get and use many different computer software developed both in house and off-the-shelf.
  • Ability to communicate ideas and information so others will understand; together with the capability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with minimal guidance or reliance on written or oral instructions and plans work schedules to fulfil goals.
  • Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
  • Ability to do under stress and multi-task.
  • Regular and constant attendance
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Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for applicants and employees according to age, race, colour, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Apply Online

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2 COMMENTS

  1. I have completed my Msc in Bioanalytical Sciences in the year 2019. Also I’ve done six months course in Pharmacovigilance and I’ve done internship for three months as a Chemical Analyst at HiMedia Laboratories.
    I’m interested in Clinical Research field also in Quality Department. Please keep me updated.

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