Job Description

Position: Senior Pharmacovigilance Specialist
Reports To: Director, Consulting; Senior Manager, Pharmacovigilance; Manager, Pharmacovigilance
Organization: Clarivate Analytics

Position Summary:
The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. Person will support the team for analysis of Literature citations for individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer\xe2\x80\x99s products.

Duties and Responsibilities:

• Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety relevant information impacting the risk-benefit and/or safety profile of customer\xe2\x80\x99s products, as per applicable regulatory requirements and standard operating procedures.
• Writes brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
• Demonstrates understanding of client\xe2\x80\x99s drugs labels and uses that knowledge effectively when performing the safety assessments.
• Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client\xe2\x80\x99s standards of timeliness and quality.
• Uses drug safety system to track all actions and assessments in an audit-ready reference history.
• Selects articles specific to client\xe2\x80\x99s interest for inclusion in client\'s product literature database per guidelines.
• Writes accurate, detailed, and complete abstracts of selected articles using good judgement regarding the level of detail required and excellent organization, grammar, and syntax.
• Extracts key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from client\xe2\x80\x99s database.
• Ensures timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
• Maintains an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
• Participates in other duties such as searches and terminology maintenance according to business needs and per the training provided.

Educational Qualifications:

• Master\xe2\x80\x99s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
• At least 5-6 years of experience reviewing biomedical literature for adverse event reporting.

o OR equivalent combination of education and experience (i.e., an information science degree with at least 5 years of relevant working knowledge of supporting drug and patient safety)

• Related experience in drug safety/ pharmacovigilance is desirable.
• Strong analytic ability to analyse and summarize the main points of biomedical case reports, studies, or specific topics.
• At least 5 years of experience using writing skills to support the creation of succinct, accurate, and precise summaries.
• At least 5 years of working knowledge of biomedical terminology, drugs, and therapeutic areas
• Proficient in database/literature searches

Ancillary Qualifications:
Qualifications listed below, while not necessarily a requirement for this position in each circumstance,
provide additional depth and value to the role.

• Certification from a professional medical writer\xe2\x80\x99s association
• Experience with commercial and client-specific biomedical literature databases
• Scientific/medical writing background

Skills:

• Excellent interpersonal, verbal / written communication skills
• Ability to work collaboratively and effectively in a team environment.
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.

The preceding job description is not intended to describe in detail the multitude of tasks that may be assigned, but rather to provide a general overview of the expectations and responsibilities of this position. As the nature of business demands change, so may the functions of this position. Additional duties and responsibilities may be assigned.

At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

Clarivate