Pharmacovigilance Scientist

Job Summary:

The Pharmacovigilance Scientist (PV-Scientist) is responsible for conducting weekly scientific literature search for the medicinal products registered, applied for marketing authorisation in United Kingdome, European Union and applied global market.

The Pharmacovigilance Scientist (PV-Scientist) acts as key personnel (primary focus) for the surveillance of scientific literature for companys and clients product as per the EMA GVP module VI. He / She is also responsible for reviewing and validate the Human EudraVigilance’s MLM and ICSR weekly database / dataset.

Subsequently, Pharmacovigilance Scientist (PV-Scientist) will be contributing / covering other segments of pharmacovigilance department like ICSR / case processing, creation and update of product information (PI), risk management plan (RMP), signal management.

Primary Role:

Surveillance of Scientific Literatures

• Surveillance of Scientific Literature routinely on weekly and Surveillance of Media on monthly basis in accordance with companies-controlled documents (e.g-SOPs, Guide) relevant regulations and guidelines.
• To set Literature search alert manually in database and PubMed on weekly basis
• Literature search in PubMed/database on daily or weekly basis for company products.
• To send and co-ordinate all Literature log for quality review on weekly basis.
• To maintain and record all literature activity log for all week.

Tangential Role –

• To select valid ICSR in accordance with companies-controlled documents (e.g-SOPs, Guide) relevant regulations and guidelines.
• To do duplicate check for all valid cases with Eudra sheet cases.
• Contributing to drafting and review SOPs, SPC, PIL, RMP, PSUR, PSMF and Signal detection for company product as per company SOP guidelines.
• Creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing) to support the drug safety reporting and information requirements of company.
• To manage and complete all assigned duties within timelines.

Necessary Skills and Abilities:

• 1-2 years of hands-on experience Pharmacovigilance
• Primary experience of surveillance of scientific literature is highly desirable but not essential
• Expert knowledge of global pharmacovigilance practices and regulatory requirements
• Strong verbal and written skills
• Ability to communicate effectively within the PV organization and cross-functionally and with all levels
• Outstanding analytical and strategic thinking skills
• Proficient organization, prioritization, and project management skills

Self-motivated and ability to motivate others.

Experience Requirements: