Safety & Pharmacovigilance Specialist – Syneos Health, Hyderabad. Apply Now!
Are you passionate about drug safety and want to be part of a global clinical development team? Syneos Health is hiring a Safety & Pharmacovigilance (PV) Specialist I in Hyderabad, India. In this role, you’ll support the collection, evaluation, and reporting of safety data throughout clinical trials and post-marketing programs. If you’re detail-oriented, thrive in fast-paced environments, and have a background in life sciences, this could be the ideal opportunity to grow your career in pharmacovigilance.
Job Opening: Safety & PV Specialist I
Location: India-Asia Pacific – IND-Hyderabad-Raheja-Mindspace
Job ID: 25001642
Description:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers.
Why Syneos Health for Safety & Pharmacovigilance Specialist:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities for Safety & Pharmacovigilance Specialist:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved as Pharmacovigilance Specialist.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintains safety tracking for assigned activities.
- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arises from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs required for Safety & Pharmacovigilance Specialist.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
- Fosters constructive and professional working relationships with all project team members, internal and external.
- Participates in audits as required/appropriate for Safety & Pharmacovigilance Specialist.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications for Safety & Pharmacovigilance Specialist:
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
- Safety Database systems and knowledge of medical terminology required.
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment as Safety & Pharmacovigilance Specialist.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
Keywords: Safety & PV Specialist I, Syneos Health, biopharmaceutical solutions, clinical development, pharmacovigilance, SOPs, clinical trials, regulatory requirements
